דרושים Quality Systems Compliance Manager ב-West Pharma ב-ארהב

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
• Understand and follow applicable ISO standards requirements
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
• Generate rejection and deviation reports as directed by site
• Perform trace back investigation of nonconforming raw material and product as directed by site
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned

• High School Diploma or GED Required

• Minimum one year manufacturing experience required

• Must poses an acute attention to detail
• Basic computer skills

Lead and manage Technology Transfers, that requires extended knowledge and relevant experience, referring to West sites and process capabilities, for the Global Sites as assigned to the timelines and objectives established. Independent work to ensure that all transfer risks are assessed and appropriate mitigation actions defined by TT team and West network experts. Enhancement of Transfer documentation templates and training of NetOp and site resources. Contribute to the TT team success managed by other leads.

• Propose and agree with NetOp QA TT execution strategy and TT scenario
• Works independently to manage technology transfer projects, globally, to the timelines and objectives established:
• TT projects high complexity, within a region
• Low and mid complexity TT projects between regions
• Manage each project encompassing all aspects of the transfer project (quality, items, customers, capacity, product strategy, transport, equipment, regulatory...)
• Work with Global QA NetOp to determine TT strategy and acceptance criteria.
• Lead and execute transfer projects using West Project Management Best Practices.
• Compiling and approval of a Project Charter, opening and closing of a Change Control
• Planning – priority, complexity, schedule, duration, required resources
• Execution – coordinate completion of all TT activities, documentation, production and testing of required batches
• Communication within West and with customers
• Active contribution in the transfer projects, as a member of a TT core team, managed by other transfer Project Managers
• Gathering and analyses of numerous required data (operation, manufacturing, quality) and information for TT Requirements plan.
• Independent preparation and completion of the Technology Transfer Risk Assessment and Risk Mitigation Plan
• Compiling and analyses of test results and providing appropriate recommendations
• Establish the operational parameters, CQA’s and acceptance criteria to be evaluated
• Guide the West resources on managing required PNR and deviation investigation
• Compiling, review and approval of Technology Transfer Equivalence Protocol (document defining documentation, references, test procedures and acceptance criteria
• Compiling, review and approval Technology Transfer Equivalence Protocol Summary Report and Customer Summary Report
• Manage review and approval of TT documents on time
• Compiling and approval of Technology Transfer Gap Assessment if required
• Ensure West global tooling experts do assessment of tools conditions and gain for their recommendation about which tools will be used for production of the TT batches.
• Manage knowledge transfer between a sending and receiving site.
• Takes a new perspective using existing solutions to recommend and apply continues improvement and optimization of transfer processes and documentation templates
• Training of less experienced NetOp colleagues

• Minimum: Master’s in Engineering or Applied Sciences

• Strong analytical, communication, and interpersonal skills.
• Robust West Pharmaceutical product / process knowledge incl. Master Control & West Quality Systems.
• Lean Six Sigma Green Belt & Minitab software
• Strong extended project management skills with the ability to deploy solutions in a global environment.
• Influence - ability to influence effectively across multiple functions and regions
• Driving execution - through determining action steps and milestones required to implement a specific business initiative; adjusts activities or timelines as circumstances warrant.
• Customer oriented mindset

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• Able to comply with the company’s quality policy at all times.
• The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments. Support and contribute in Lean Sigma programs and activities towards delivery of the set target.

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.

• Designing and implementing Business Intelligence (BI) solutions throughout the organization.
• Establishing and developing relationships with key internal stakeholders to understand the distinct BI needs across all business departments and support the service delivery.
• Building and preserving productive relationships with a broader business network, IT associates, and vendors, while addressing and resolving potential issues.
• Aiding in the creation of a uniform approach towards the execution of BI projects.
• Overseeing multiple BI projects, ensuring smooth progression from inception to completion.
• Offering maintenance services for existing BI solutions and serving as the primary escalation point for issues related to BI projects.
• Bridging the gap between business necessities and technical considerations, negotiating solutions, and encouraging creativity when feasible.
• Contributing to the ongoing growth and delivery of BI services, inclusive of projects, while ensuring constant protection and security of business data.
• Define and translate business rules and processes into S4 Hana data solutions
• Lead projects impacting data integration for manufacturing KPI’s
• Providing guidance, templates, reporting and instructions to Supply Chain, Operations, Quality, Warehousing and Finance regarding the required maintenance of Master Data and transactions.
  • E.g. Tier meeting dashboards, reports such as OEE, scrap, sales & absorption
• Supporting equipment interfacing needs.
  • E.g. Intouch & Edart MRP’s
• Supports and continuously improves procedures and processes related to but not limited SAP S4 Hana & Power Bi.
• Other duties as assigned.

• Bachelor's degree in computer science, business or related field; or equivalent work experience.

• Related SAP & Power BI Work Experience: Minimum 5 years of experience
• A minimum of 5 years’ experience in a Business Analyst role or a similar position with relevant experience.

• Experience in delivering or managing BI projects.
• Familiarity with high-volume manufacturing operations.
• Proven ability to manage multiple projects simultaneously, demonstrating excellent multitasking and prioritization skills.
• Proficiency in translating technical language into comprehensible terms.
• Experience in implementing, configuring, and testing BI solutions.
• Experience in developing within the Microsoft Power Platform environment, with a focus on Power BI, Power Automate, and Power Apps.
• Working knowledge of Microsoft Power BI Desktop, management of Microsoft Teams groups, OneDrive storage, and Microsoft SharePoint.
• Proficiency in using Microsoft 365 applications, with an understanding of its interconnections with Microsoft SharePoint and Microsoft Power Platform.
• Experience in data extraction, cleansing, and integration.
• Understanding of Lean Manufacturing principles, such as Value Stream Maps, Continuous Improvement, and Kaizen.
• Ability to accurately document work performed.
• Ability to work independently on own projects while working concurrently with all departments.
• Awareness of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification within 1 Year required

• Self-motivated, results- and solution-oriented personality
• Very good organizational and project management skills
• Highly analytical and structured way of working
• Ability to successfully collaborate with teams across different countries and organizational levels
• Fluent in English
• Proficient in Microsoft based programs
• Ability to assert technical solutions and standards in an international environment
• Excellent communication skills and ability to collaborate well with people across different countries
• Manage working with colleagues in different time-zones
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

In this On-Site role you will coordinate business unit lean savings, goals and objectives through the use of statistical techniques by planning, scheduling, and executing process projects. You will communicate project status, and define and shape strategic planning efforts, including critical goal and objective development that identifies and improves critical processes necessary to achieve annual targets, including waste reduction to drive technical and operational improvement.

• Participate in the development and support of the West Business System (WBS), with the goal of sustaining operational standards on the site.
• Create and manage strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
• Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
• Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
• Organize and/or assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
• Sets up and/or participates in continuous improvement events related to establishing a process or process improvement.
• Ensure that workplace process improvements are visible, that savings are tracked, validated and posted.
• Review control charts/data generated from facility processes to assure they are in a state of statistical control.
• Manage capital and non-capital projects to improve capacity, quality, efficiency, utilization and safety at the lowest cost. Manage projects by maintaining project timelines and continuously evaluating actual project costs with budgeted costs so projects will be completed on budget and in a timely manner.
• Collaborate with QA and Engineering to set up and conduct capability studies, designed experiments, sampling programs, process validations, etc. to evaluate the manufacturing capability of products/ processes, and provide input, analysis and actions related to the data generated from these studies.
• Assists with facility/supplier audits and meetings, as required.
• Performs other duties as assigned based on business needs

• Bachelor's Degree in Business, Engineering, or recognized equivalent required

• Minimum 8 years experience as an Operational Excellence manager or equivalent required
• Minimum 5 years experience in a manufacturing/production environment, utilizing Lean Manufacturing Principles required

• Must have good interpersonal/leadership skills and be able to interface with all departments and team member levels.
• Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
• Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Install and control adequate protection of confidential information and documentation. Ensure that key operational and essential documentation files kept on computer or otherwise are properly backed up at all times.
• Restrict access to confidential information as required.
• Work closely with other functions to maximize achievement through a cooperative environment
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• The position holder is responsible to consider the safety and health of our employees when designing or improving our workplaces. As a leader he educates and trains our employees on the importance of safety and acts as a role model.
• Able to comply with the company’s quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378, DIN EN ISO 9001 and DIN ISO 50.001 as per its current state and also as it applies to any future amendments

• Manufacturing\Lean Six Sigma Black Belt LSS Champion, LSS Green Belt or LSS Black Belt Upon Hire preferred

Senior Engineer, Quality Systems supports and executes the effective development, implementation, and continuity of the Quality Management System (QMS) at a site and business unit level, ensuring compliance with ISO 13485, EUMDR, GxP, and other regulatory requirements. This role encompasses responsibilities such as supporting and managing the CAPA program(s), non-conformance process(es), management review(s), audit(s), document control, etc. Sr. Engineer, Quality Systems collaborates with business leaders to create and maintain efficient quality system programs, driving change management and continuous improvement initiatives. Provide training on quality best practices and utilize ISO 14971 risk management techniques to ensure alignment with quality requirements. As a key communicator, this position demands excellent written and verbal skills to engage confidently across organizational levels. The role requires meticulous documentation practices, adherence to good manufacturing practices, and active participation in continuous improvement projects, ensuring a safe work environment and compliance with company policies and regulatory standards. This is an onsite role based in Scottsdale AZ.

• Contribute to the enhancement of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820, ISO 13485, EUMDR, GxP, and relevant regulatory requirements.
• Collaborate with departments and sister-sites to set and maintain quality objectives, metrics, and programs.
• Coordinate and prepare critical information for Management Reviews and safeguard key performance metrics (KPIs) within compliance frameworks.
• Manage the non-conformance system to guarantee comprehensive documentation and resolution of incidents.
• Support internal and external audits by regulatory bodies and clients, ensuring compliance with established quality standards.
• Drive effective change management processes at a site and business unit level, assessing product/process modifications against quality requirements.
• Train staff to procedures and quality best practices, fostering an organization-wide quality-centric culture.
• Utilize ISO 14971 risk management techniques to mitigate risks in product development and manufacturing processes.
• Develop and uphold robust procedures for quality system elements per ISO 13485.
• Identify and propose process improvements to enhance quality and operational efficiency.
• Oversee the Corrective and Preventive Action (CAPA) process, ensuring thorough investigation and resolution through the CAPA Review Board (CRB).
• Facilitate root cause analysis, implementing CAPA to address quality issues and support continuous improvement initiatives.
• Maintain a high level of scrutiny in reviewing and approving CAPA investigations and extensions.
• Provide detailed reports and insights on QMS performance to senior management.
• Align activities with regulatory guidelines such as FDA 21CFR Part 820, ISO 13485, GxPs, and ISO 14971.
• Adhere to all regulations, policies, and safety protocols consistently.
• Maintain punctuality and reliable attendance, adhering to a customer service-oriented approach.
• Keep a clean, orderly, and safe working environment.

• Education: Bachelor's Degree in Engineering or Science or equivalent experience required
• Work Experience: 5-8yrs of experience in a Quality Management System (QMS) or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential (medical device manufacturing preferred).
• Proven track record in handling Quality System Procedure(s), CAPA, non-conformance, and audits as part of a QMS. Proficient knowledge of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.
• Regulatory and QMS Knowledge: Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR. Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.
• Skills and Competencies: Strong analytical and problem-solving skills, particularly in non-conformance, CAPA, and root-cause analysis. Excellent organizational skills and the ability to communicate effectively at various levels of the organization. Proficiency in working within a team-oriented environment with strong interpersonal capabilities.

• Technical Proficiency: Demonstrated expertise in computer skills and familiarity with quality-related software and tools including EDMS and SAP.
• Deadline & Project Management: Proven ability to efficiently meet deadlines in a fast-paced, changing environment.
• Problem-Solving Expertise: Strong problem-solving skills with knowledge of Lean Six Sigma methodologies being advantageous.
• Root Cause Analysis: Proficient in Root Cause Analysis methodologies such as A3, 5 Why’s, 6M’s, 8D’s, and DMAIC.
• Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards, including 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, and GDP.
• Analytical Skills: Strong data analysis skills with knowledge of statistical requirements for sampling plans (application of Minitab statistical software, preferred).
• Organizational Skills: Highly organized, detail-oriented, and self-motivated with project management expertise.
• Communication Skills: Experienced in report writing with clear and effective communication, and experience working with manufacturing operations. Ability to communicate with and to multiple levels and positions within the organization.
• Validation Expertise: Skilled in validation processes and experienced with manufacturing operations.
• Collaborative & Independent Work: Ability to work effectively both individually and as part of a team, with the capability to engage and leverage others to accomplish projects.
• Procedural Awareness: Ability to develop, understand, and adhere to all relevant standard operating procedures as per company policies and regulations related to this role

Certification in Quality Engineering (CQE) or as a Certified Quality Auditor (CQA) is preferred.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for technicians.
• Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Education: Associate degreein Engineering or Science field

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.
• Some validation experience – computer systems, equipment and process required and

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy and quality policy at all times.

• Manufacturing\Lean Six Sigma Certification-IASSC or Agile preferred
• Program and Project Management\Certified Project Management Professional (PMP)-PMI Knowledge of Agile and Waterfall methodologies preferred

The incumbent will be a strong advocate of quality systems and quality culture with the drive, experience and knowledge to be able to provide mentorship and direction on best practices.

The position can be located at any West site and is not limited to Exton.

• Ensure success of assigned projects by overseeing all aspects of project planning, resourcing, communications, problem solving etc.
• Coordinate Quality Culture events and initiatives such as Quality Culture workshops, recognition programs, customer visits etc.
• Establish and lead cross-functional quality-related meetings to review and discuss performance, status and prompting necessary actions as required.
• Partner with L&D, HR and other relevant functions to drive improvements to employee onboarding and training.
• Partner and/or liaison with other West functional areas to drive optimization of processes and procedures and bring resolution to issues.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Report out on projects and initiatives to Executive and Senior Leadership as requested.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• All other duties as required.

• Bachelor's Degree or equivalent experience required
• Master's Degree preferred

• Minimum 8 years Quality or related experience required
• Experience in regulated industry such as pharmaceutical and medical device preferred
• Experience with SAP and MasterControl systems preferred

• Project Management skills, able to manage multiple projects across the globe
• Ability to to forsee potential problems and navigate challenges efficiently all while maintaining a strong focus on stakeholder requirements and project goals.
• Strong interpersonal skills and ability to communicate at all levels of the organization e.g. during Global townhalls etc.
• Ability to work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions
• Knowledge of cGMP, cGDP, relevant ISO standards and medical device/Pharma requirements
• Ability to adhere to all company safety and quality policies

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems