דרושים Hris Project Specialist ב-West Pharma ב-United States, West Whiteland Township

The HRIS Project Specialist has responsibility for supporting the delivery and execution of West’s HR Projects.

Portfolio Management

• Drive transparency of project workloads, commitments and expectations by managing reporting and dashboards out of the West Project Management system.
• Champion of the HR PMO processes and the agile methodology.
• Support departments with the setup and maintenance of projects within the West Project Management system.
• Build and maintain strong relationships with customers, business partners, resource managers, and other senior level executives.

Project Management

• Manage smaller projects as assigned by the HR PMO.
• Maintain the project related data and documents within the West Project Management System.
• Define, drive and manage change management and communications activities that support assigned projects.

Harmonization

• Work closely with HR leaders and stakeholders to standardize HR processes globally.
• Drive harmonization of different approaches across global locations
• Develop strategies to ensure consistency and efficiency in HR operations.

Training and Support

• Develop training materials and provide support to teams during process implementation.
• Ensure that team members understand and adhere to new processes.

Other duties as assigned.

• Bachelor's degree in Human Resources, Business Administration, or a related field or equivalent experience
• 3-5 years experience in Project Management, preferably in HR operations.

• Excellent analytical and problem-solving skills.
• Ability to work independently and collaboratively in a global, multicultural environment.
• Exceptional communication and interpersonal skills, with the ability to communicate effectively with colleagues across the company from SME to Management teams
• Self-motivated and dynamic individual who is able to challenge and influence others, develop and maintain collaborative working relations across HR and other functions at West
• Familiarity with HRIS (Human Resources Information System) platforms.
• Project management skills with the ability to manage multiple tasks and priorities.
• Proven experience in managing projects related to HR process improvement.
• Familiarity with Agile or other project management methodologies.
• Experience coordinating and leading cross-functional project teams.
• Ability to comply with the company’s safety and quality policy at all times.

• Must be able to travel up to 10% of the time

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• 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
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

The HR Project Specialist has responsibility for supporting the delivery and execution of West’s HR Projects.

Portfolio Management

• Drive transparency of project workloads, commitments and expectations by managing reporting and dashboards out of the West Project Management system.
• Champion of the HR PMO processes and the agile methodology.
• Support departments with the setup and maintenance of projects within the West Project Management system.
• Build and maintain strong relationships with customers, business partners, resource managers, and other senior level executives.

Project Management

• Manage smaller projects as assigned by the HR PMO.
• Maintain the project related data and documents within the West Project Management System.
• Define, drive and manage change management and communications activities that support assigned projects.

Harmonization

• Work closely with HR leaders and stakeholders to standardize HR processes globally.
• Drive harmonization of different approaches across global locations
• Develop strategies to ensure consistency and efficiency in HR operations.

Training and Support

• Develop training materials and provide support to teams during process implementation.
• Ensure that team members understand and adhere to new processes.

Other duties as assigned.

• Bachelor's degree in Human Resources, Business Administration, or a related field or equivalent experience
• 3-5 years experience in Project Management, preferably in HR operations.

• Excellent analytical and problem-solving skills.
• Ability to work independently and collaboratively in a global, multicultural environment.
• Exceptional communication and interpersonal skills, with the ability to communicate effectively with colleagues across the company from SME to Management teams
• Self-motivated and dynamic individual who is able to challenge and influence others, develop and maintain collaborative working relations across HR and other functions at West
• Familiarity with HRIS (Human Resources Information System) platforms.
• Project management skills with the ability to manage multiple tasks and priorities.
• Proven experience in managing projects related to HR process improvement.
• Familiarity with Agile or other project management methodologies.
• Experience coordinating and leading cross-functional project teams.
• Ability to comply with the company’s safety and quality policy at all times.

• Must be able to travel up to 10% of the time

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• 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
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

In this role, you will be accountable for facilitating, managing and maintaining the OPMO governance, structure, processes & standards, data, metrics and communication plan. This position will ensure key deliverables of the PMO are met and the Organization is supported.

• Lead communicator to OPMO project team on updates to governance, processes and templates.
• Facilitate the preparation, presentation and archiving of key OPMO meetings per communication plan – such as, but not limited to Project Requests / Proposals, Status Updates and Phase Gates.
• Facilitate and schedule Ad Hoc meetings as required.
• Maintain key stakeholder lists for key OPMO meetings, adjust as necessary.
• Ensure key stakeholder attendance or designates when necessary for key OPMO meetings.
• Ensure templates and project standards are developed or updated, properly trained and communicated within OPMO project team, network project managers and Operations.
• Maintain OPMO TEAMS governance site and OPMO SharePoint site.
• Maintain the master list (Portfolio) of projects across OPMO, West Network of select non-OPMO projects and key metrics and data. Azure or related updates to support master list. Current / Future State value stream mapping of OPMO processes as required.
• Provide leadership and support for resource tracking and forecasting tools that can be used across the organization.
• Work with key members of the OPMO to develop reporting requirements and run reports related to project and resource costs.
• Lead the development and maintenance of reporting mechanisms to enable the broader management team to make informed decisions regarding resource deployment, prioritization and program related financial assessments.
• Support with data the Program Management escalation of key issues arising from the plan / metrics to Senior management where necessary.
• Ability to organize and prioritize tasks, must be detail oriented and self-motivated.
• Support portfolio and cost center managers with information requests related to open commitments by project or cost center.
• Ability to work independently on own projects while working concurrently with all departments.
• Maintain an up to date understanding of the SAP functionality.
• Other duties as assigned.

• Bachelor's Degree or equivalent experience in a science, engineering, or IT discipline.

• 3-5 years working in a cross functional manufacturing environment interacting with senior management.
• Experience in manufacturing environment preferred

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• A knowledge of Microsoft Office, MS Project, MS Teams, Visio, Azure Dev Ops and Power BI
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Comfortable working in a manufacturing environment.
• Specific vision abilities may be needed by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
• Must be able to tolerate heat and industrial odors/smells on a frequent basis.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.

• Providing differentiating service for Strategic Accounts, owning our customers journey
• Aligning with Global counterparts to create one global customer experience
• Serving as SPOC for all customer relationship matters within the assigned accounts
• Identifying key customer stakeholders and develop strategies to build trusted advisor relationships with them
• Maintaining a regular interaction with assigned accounts to proactively identify potential issues and additional potential opportunities
• Champion for Customer Experience Improvement in close cooperation with Digital Customer Experience unit
• Sustaining a sense of urgency across the organization to solve customer issues
• Customer Satisfaction, as measured by NPS (Net Promoter Score)
• Handling daily customer interactions professionally and patiently by phone and email
• Working closely with Technical Customer Support and Sales Account Managers including participation in business reviews, customer specific projects, supply chain meetings etc
• Informing customers of interruptions to order schedule and review next best outcome together
• Assisting in providing reporting to customer: open order schedules, forecast, lead time reports, and sales history, following up on transport queries, Track and Trace
• Managing deviation agreements
• Assisting in resolving invoicing discrepancies with internal AR, supporting the Dunning process
• Process owner for Customer Dialogue whilst still maintaining common sense approach to simple tasks
• Performs other duties as assigned

• Knowledge or experience with ERP tools like SAP with Sales and Distribution required
• 3+ years of experience in client services or customer service required
• 2+ years of direct experience in customer interaction roles preferred

• Working knowledge of MS Office or the willingness to learn it quickly
• Ability to deliver great customer experience and to be invigorated by constant personal interaction
• Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Strong learning capacity
• Ability to work independently in global environment
• 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 and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• 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
• Position operates in a professional office environment. May stand or sit for extended periods of time
• 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

• High School Diploma, GED, vocational training (apprenticeship), or appropriate professional experience required

In this role as a Quality Assurance Specialist at West Analytical Lab Services, you will be instrumental in providing quality support and ensuring the continuity of cGMP compliance, in line with corporate policies and procedures. Your responsibilities will include ensuring the lab's adherence to regulatory, compendial, ISO, and West requirements while reviewing the quality of work completed by lab personnel. You will be tasked with analyzing data, recommending changes, and verifying their effectiveness, alongside reviewing and approving investigations, corrective actions, validation documents, and relevant change control documentation. By leveraging your knowledge and experience, you will drive initiatives to enhance system effectiveness and efficiency, ensure timely completion of assignments, and support the development and review of lab procedures and work instructions. Additionally, you will play a key role in resolving quality issues, maintaining consistent application of quality requirements, and contributing to the technical writing and editing of procedures and documentation.

• Provides QA support to Analytical Lab ensuring compliance to regulatory/compendial, ISO and West requirements.
• Reviews the quality of work completed by the Lab personnel to ensure it meets regulatory/compendial requirements, ISO, West procedures, and customer requirements.
• Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness.
• Reviews and approves the investigations, corrective actions, validation documents and reports, and change control documentation related to Exton Lab.
• As appropriate, use knowledge and experience to take initiatives to improve the effectiveness and/or efficiency of systems.
• Ensures that assignments are completed on time, and at the required level, etc.
• Provides support for the development of procedures and work instructions for the lab including technical editing and writing.
• Participates in the review of lab procedures and work instructions.
• Resolves issues within Quality to ensure consistent application of quality requirements.
• Participates in internal quality audits and customer audits.
• Reviews and provides approval of materials from external warehouses.
• Provides client’s supplier qualification questionnaire response.
• Prepares data and information to be discussed during Management Review and ensure that this review is performed per procedure.
• Supports corporate harmonization initiatives as they pertain to the lab management system.
• Works independently with minimal supervision.
• Performs other duties as assigned based on business needs.

• Strong communication and technical writing skills, interpretation of data, and interpersonal skills.
• 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.

• Education or Equivalent Experience: Bachelor's in scientific discipline preferred. Applicable work background and experience may be considered as a substitute.

• Minimum 3 years of experience in regulated Quality Assurance / Quality Control required
• Minimum 3 years of experience in medical devices or pharmacy industry preferred

• Knowledge of cGMP requirements and ISO standards
• Ability to work independently, multi-task and thrive in fast-paced environment
• Experience with managing Document Control activities within a regulated industry
• Familiarity with Master Control, SAP/ERP system and SharePoint
• Excellent written and verbal communication skills
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Able to be aware of all relevant SOPs per Company policy as they are related to the position covered by this Job Description.
• Must have effective problem solving and interpersonal skills
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to always comply with the company’s safety policy.
• Able to always comply with the company’s quality policy.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Must maintain the ability to work well with others in a variety of situations
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers

• Support West customers in technical matters relating to: * Drug-closure compatibility* Packaging recommendations * Component processing * Functionality * Product/packaging development * Extractable/leachables and other test requirements * Other information as needed to help assure West products will meet their requirements
• Take a proactive role as technical interface between the customer and West’s functions: * Be an active part of the account teams* Support development of commercial strategies for products / services and customers * Represent the Voice of Customer to the West organization * Update the Sales teams on technical issues/projects within customers: * Interface with customers and account managers to obtain the background information and customer’s technical requirements on projects * Advise on the status of and drive / follow up on technical aspects of internal and external customer-linked projects
• Promote, present and actively participate in growing West business: * Prepare technical presentations * Conduct technical seminars / symposiums with customers * Educate customers on product applications * Share industry insights with customers
• Participate in external thought leadership: * Attend and participate in tradeshows, conferences and seminars, with presentations to customers / industry as needed * Act as a liaison between customers, Sales and West Analytical Laboratories. * Build expertise in key market knowledge areas over and above the internal trainings. * Work closely with all other members of Global Technical Customer Support team to assure open communication and a high level of effectiveness

• Bachelor's Degree Bachelor's in a technical field (Chemistry/Biology/Engineering) required

• Minimum 3 years of experience in technical support, analytical laboratory, research and development, or engineering role required and
• 1-2 years of experience in related fields, e.g., pharmaceutical, or medical device industry required

• Proactive, competitive, presentation, problem solving, communication, analytical, prioritization, detail oriented, technical, personal accountability
• With a moderate level of guidance, works well in a fast-paced environment
• Ability to comprehend technical information
• Strong interpersonal skills: able to connect with others and manage relationships
• Ability to utilize sound judgment and manage multiple priorities with a sense of urgency
• Ability to identify internal and external client needs and make appropriate recommendations
• Ability to work in a virtual environment in a global organization
• Excellent English language skills (written/oral)
• Willingness to global travel

• Must be able to understand direction and adhere to established procedures

Sr. Specialist,Regulatory Affairs, Medicalis responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations,including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements.

• Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
• Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Provide leadership to cross functional teams for regulatory issues and questions.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required

• Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline

• 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration, US 510(k) and/or EU technical documentation submissions

• Advanced knowledge of ISO 13485
• Attention to detail with planning, time management and organizational skills
• Regulatory compliance competency including Quality Systems
• Experience with administration and safety systems preferred
• Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.