דרושים Operator Supply Chain Warehouse M/f/d Esw ב-West Pharma ב-Ireland, Waterford

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.

The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
• Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
• Review and approval of laboratory test results
• Ensuring Data Integrity of laboratory results
• Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications
• Communication with External Customers
• Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
• Review and approve sampling plans & procedures related to manufacture of products.
• Lead and perform risk assessments and implement control plans.
• Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and user acceptance testing where required.
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services and production and timely resolution of issues and investigations.
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as required

• Degree in a Quality, Science or Engineering or equivalent discipline.

  Desired:

  • Quality Auditing certification.
  • Lean/Six Sigma certification.
  • Supervisory experience.

• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.
• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.
• 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

In this role, you will perform quality inspection, sampling and quality control testing against approved specifications on incoming, in process and finished products.

• Ensuring all incoming materials, packaging components and returned goods are sampled, inspected, labeled & tested (where applicable) for determining compliance with established specifications and COA/COC.
• Completion of associated documentation and records.
• Generate associated OOS/Deviation/Non-Conformances
• Input of data into the enterprise resource management system.
• Using testing and measuring equipment to conduct inspections.
• Reviews completed production documentation including Worksheets, Batch Cards, logs and any other associated data for correctness/completeness and disposition of in process materials as appropriate.
• Compilation of inspection and testing data to support trending
• Participates in daily production and other scheduled meetings as required
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned

• Minimum Leaving certificate required.
• Third level science/engineering qualification is desired.

• Ideally, min 2 years experience in similar role
• Familiarity with SAP/ERP system, SharePoint is desired
• Fluent with Microsoft Office (Word, Excel, Outlook)
• Natural ability to work in team-oriented environment
• Good communication skills
• Attention to detail.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.

In this role you will be responsible for Material Master set ups relevant to Waterford Supply Chain, whilst reviewing and maintaining the site medium- long term horizon planning. Working with cross functional teams you will ensure all master data is accurate and set up in a timely manner ensuring any New Product Introductions are coordinated and tracked from initial set up through to production. You will continually review the level loading of production volumes ensuring all customer orders are scheduled in sequence to meet required shipping dates.

• Set Up Material Master, BOM, Recipe and Shop Floor System for all Finished Goods as per the Promenta process.
• Set up Material Master for SFGs, Raw Materials and Consumables as per the Promenta process.
• Complete New Item Checklists for all new items scheduled for production for the initial production run.
• Maintain alternate production versions of Material Master Data where necessary for envision product
• Ensure Master Data is set up to print customer item number on product labels where required.
• Maintain Recipe Templates for different Process Types – RS, RU, Gamma, RU only etc.
• Proactively liaise with Data Governance and I.T. to solve Master Data issues.
• Maintain and publish relevant KPIs as required
• Create, develop and analyse SAP BI Reports to support key decisions within Supply chain dept.
• Maintain Power BI dashboard - extracting data as per business perspective to improve the business process.
• Ensure Resources are set up correctly. Maintain Pooled Resources where required
• Coordinate a cross-functional team to review, once per year and as a project, all parameters, routings, and standard costs for every SKU.
• Liaise with Data Governance for Mass Upload requests.
• Work with site stakeholders on New Product Implementation tracking the SKUs from set up to production.
• Planning Responsibilities:

• Plan and execute master production schedule – COOISPI, co-ordinating with global planning and plant supply chain to monitor adherence to the plan.
• Lead the planning process for the sheeting area
• Ensure customer orders are scheduled correctly in line with shipping schedule, identify any potential scheduling constraints level loading production as required.
• Review and monitor weekly absorption adherence
• Support printing of batch cards when required

• Update relevant SOIs in relation to the current processes

• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.

• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned

• • 3rd Level qualification in Supply Chain, Engineering or similar
  • 5+ years in a similar role ideally within a pharmaceutical or medical device environment.
  • SAP experience required

• Detail orientated and self-motivated.
• Experience in Project coordination
• Ability to prioritize and respond timely to changing requirements, and to coordinate multiple tasks simultaneously and accurately.
• Good organizational, facilitation and excellent communication skills both written and oral required.
• Knowledge of computer software MS office; Word, Excel.

• Manage production flow and output, by carrying out a range of functions including tracking product at each stage of the process, proper labelling and inventory management using Kanbans and automated MES and Plc based systems, to ensure optimum equipment uptime and target outputs.
• Equipment includes, but not limited to -washers, autoclaves, envision, envision tooling, inner pack, outer pack-staging/ material handling, mixing-weighing, drop mill, feed mill, calendar, winder, rotocure and slitter machines).
• Adhere to standard operating instructions for proper PPE and gowning for entry to production, quality, labs and clean room areas.
• Prepare, set-up and clean machines as per requirements. Adhering to housekeeping and materials management policies in all production areas while focusing on continuous process improvement using Lean Principles.
• Clean room cleaning
• Gather, record and label samples for testing by QA & Lab departments. Ensuring correct documentation is available and or provided.
• Carry out product testing and records results as required.
• Maintain process equipment, assisting & completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
• Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials for various systems; ensure all work is carried out in line with same.
• Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g. FMEA, A3/A4
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Understand the specific responsibilities of all departments as they relate to one’s own department, understanding the business processes one’s department supports.
• Work collaboratively to drive a safe and compliant culture. Compliance to all local site Environmental, Health and Safety regulations.
• Adheres to methods/procedures and policies to meet the requirements of Quality Systems and Environmental Management Systems.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned.

• Apprenticeship, Certificate or Diploma preferred; ideally in a mechanical, manufacturing related discipline.
• Minimum Education: Leaving Certificate

• Ideal candidates would typically have 1-3 years prior work experience in the Bio Pharmaceutical /Pharmaceutical or Medical Device Industries, or in another GMP setting.

• Knowledge of Good Manufacturing Practises (cGMP) requirements would be an advantage
• Shift work (2/3/4 shift)
• Proficiency in Microsoft Office and job related computer applications
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Must be able to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and process specification, and ensure that all associated paperwork is completed accurately.
• Must be willing to work in a controlled cleanroom environment, which involves the wearing of a gown, cap and relevant personal protective equipment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

Competencies:

• Self-motivated
• Flexible approach
• Effective time management and multi-tasking skills
• Excellent attention to detail
• Trouble shooting skills
• Goal/results orientated
• Good verbal reasoning, numerate ability
• Excellent mechanical aptitude
• Strong communication skills, both written and oral.
• Proven ability to work in a team environment
• Strong organisational skills.

• Responsible for the Production Planning, Raw Material Planning/ordering, Raw material & Finished Goods Warehouse as well as master data accuracy in SAP. Managing the Plant Supply Chain activities with the focus on achieving the targeted OTIF (On-Time in Full) for customer deliveries or deliveries to other plants of West Pharma as requested by the internal/external customers.
• Manage a proper balance between financial targets, production targets (low production variability, high utilisation of equipment, good OEE performance – e.g. reduce losses through set-up times) and customer service/requirements.
• Managing the ordering of raw materials and ensure a proper supply to the related production departments to enable in-time production as scheduled.
• Continuous controlling & monitoring of major KPI´s (OTIF customer & supplier, Schedule Adherence, Inventory DOS, Late List, Lead Time, clean-to-build), analyze root-causes of deviations and implement actions for improvement.
• Lead and develop the Planning and warehousing teams.
• Manage appropriate inventory levels on raw materials, semi-finished and finished goods.
• Build-up an agile Supply Chain approach in terms of flexible shift models, implement processes guaranteeing higher flexibility (e.g. FTO), flexible packaging lines and other related actions.
• Ensure that production planning is carried out in SAP. Regular check of all SCM relevant Master Data Settings in SAP and MES.
• Close cooperation with Production and Quality Departments to ensure, that a high level of customer service can be kept at any time. Support the monthly target setting and forecasting process in terms of plant output, cost absorption, inventory and shipment planning. Carry out capacity planning (short and long term) and modelling so that pinch points can be identified and required actions taken. Build a local S&OP process to guide site operations.
• Cooperation with other West plants for identifying and realizing synergies to contribute to company targets. Support the creation and the controlling of Budgets for the own area of responsibility. Create reports and analysis on a regular basis as requested by Plant Management or Corporate Functions in order to support the regular Budget-, Review- and Planning Meetings of West.

• Degree level qualification in Business, Business Engineering, SCM is required
• Master's level is an advantage

• 7+ years of experience in relevant Supply Chain function

• Experience in leading Supply Chain teams

• Experienced in Lean Manufacturing concepts & approaches with special focus on production planning

• Excellent analytical and conceptual skills .
• Design and application knowledge of SAP supply chain tools, with special focus on SAP ERP .
• Supply Chain Optimization along the Product Life-Cycle
• Target driven and result oriented.
• Experience in a cGMP environment.
• Strong competence in IT
• Good verbal and written communication skills
• Excellent interpersonal skills with the ability to work with all levels within the Organization, suppliers, customers and external contractors
• Team player.

• Being able to make decisions and take tangible actions appropriate.
• Result Oriented
• Analytical Skills
• Positive mindset
• Good communication skills over all hierarchical levels
• Strong Teamwork.
• Being able to conclude the big picture out of details.
• Project Management.

The Warehouse Manager oversees and manages all warehouse operations, ensuring seamless processes for receiving, identifying, storing, handling, and distributing materials in accordance with site procedures and business unit requirements. This role is pivotal in ensuring good support and materials availability for operations, that all warehouse-specific materials are ordered effectively, meticulously tracked, and inventories controlled to maximize operational efficiency. This position spearheads the shipment of products to align with site procedures and exceed customer specifications, fostering an environment of excellence, continual improvement, and a vibrant workplace culture.

• Oversee and manage the comprehensive operations of warehouses, including pick of materials for operation, management of incoming materials and shipment of finished goods.
• Interface with purchasing and planning departments to ensure production schedules are met with precision and efficiency.
• Coordinate and expedite the delivery and flow of materials and supplies essential for the production process, while optimizing warehouse utilization.
• Conduct physical inventories and cycle counts of stock items to ensure accuracy.
• Order warehouse-specific materials and supplies based on established stock levels.
• Compile and analyse statistics and reports on usage, stock levels, and on-time delivery rates.
• Ensure site shipments adhere to all policy and procedural requirements, guaranteeing timely delivery of products to customers.
• Maintain accurate records for all goods shipped or received.
• Lead initiatives to promote site safety programs, lean methodologies, and continuous improvement projects.
• Cultivate a positive workplace culture by managing team performance through regular performance reviews, 1:1s, recruitment, training, and development plans, swiftly addressing any arising issues.
• Foster communication and cooperation among team members, promoting knowledge sharing and collaboration.
• Participate in resolving team member relations issues and facilitate team transitions to different locations, as needed.
• Collaborate with transportation and logistics providers to optimize on-time delivery performance and quality at competitive rates.
• Ensure all employees are adequately trained and remain informed in their areas of responsibility.
• Exhibit a "Customer Service" attitude in interactions, achieving work tasks while maintaining required quality standards.
• In the absence or unavailability of a warehouse worker or administrator, carry out authorized transactions: create inbound deliveries for SAP items, ensure stock entry, submit arrival notifications, and manage goods in the warehouse; facilitate material transfer utilizing SAP transactions.

• Bachelor’s Degree in Supply Chain, Business Studies, or similar discipline is an advantage
• APICS qualification is an advantage
• Advanced proficiency in Microsoft Excel, Word, and PowerPoint.
• Experience with Shop Floor Systems to manage plant operations effectively, including ERP and MRPII systems.
• SAP experience preferrable

• 5 years of experience in Warehousing, Operations, Purchasing, Planning, or Inventory Level Management, preferably in the pharmaceutical industry.

• Strong experience in applying Lean Manufacturing principles.
• Excellent coordination and organizational skills.
• Ability to perform effectively under pressure.
• Team player with the capability to handle multiple tasks simultaneously and persistence in following up requests.
• Excellent communication and interpersonal skills.
• Strong problem-solving skills with the ability to analyse data and reach solutions.
• Good negotiation and conflict resolution skills.
• Ability to work independently with involvement across multiple business functions.
• Strong sense of urgency and flexibility.

• Responsible for the Production Planning, Raw Material Planning/ordering, Raw material & Finished Goods Warehouse as well as master data accuracy in SAP. Managing the Plant Supply Chain activities with the focus on achieving the targeted OTIF (On-Time in Full) for customer deliveries or deliveries to other plants of West Pharma as requested by the internal/external customers.
• Manage a proper balance between financial targets, production targets (low production variability, high utilisation of equipment, good OEE performance – e.g. reduce losses through set-up times) and customer service/requirements.
• Managing the ordering of raw materials and ensure a proper supply to the related production departments to enable in-time production as scheduled.
• Continuous controlling & monitoring of major KPI´s (OTIF customer & supplier, Schedule Adherence, Inventory DOS, Late List, Lead Time, clean-to-build), analyze root-causes of deviations and implement actions for improvement.
• Lead and develop the Planning and warehousing teams.
• Manage appropriate inventory levels on raw materials, semi-finished and finished goods.
• Build-up an agile Supply Chain approach in terms of flexible shift models, implement processes guaranteeing higher flexibility (e.g. FTO), flexible packaging lines and other related actions.
• Ensure that production planning is carried out in SAP. Regular check of all SCM relevant Master Data Settings in SAP and MES.
• Close cooperation with Production and Quality Departments to ensure, that a high level of customer service can be kept at any time. Support the monthly target setting and forecasting process in terms of plant output, cost absorption, inventory and shipment planning. Carry out capacity planning (short and long term) and modelling so that pinch points can be identified and required actions taken. Build a local S&OP process to guide site operations.
• Cooperation with other West plants for identifying and realizing synergies to contribute to company targets. Support the creation and the controlling of Budgets for the own area of responsibility. Create reports and analysis on a regular basis as requested by Plant Management or Corporate Functions in order to support the regular Budget-, Review- and Planning Meetings of West.

• Degree level qualification in Business, Business Engineering, SCM is required
• Master's level is an advantage

• 7+ years of experience in relevant Supply Chain function

• Experience in leading Supply Chain teams

• Experienced in Lean Manufacturing concepts & approaches with special focus on production planning

• Excellent analytical and conceptual skills .
• Design and application knowledge of SAP supply chain tools, with special focus on SAP ERP .
• Supply Chain Optimization along the Product Life-Cycle
• Target driven and result oriented.
• Experience in a cGMP environment.
• Strong competence in IT
• Good verbal and written communication skills
• Excellent interpersonal skills with the ability to work with all levels within the Organization, suppliers, customers and external contractors
• Team player.

• Being able to make decisions and take tangible actions appropriate.
• Result Oriented
• Analytical Skills
• Positive mindset
• Good communication skills over all hierarchical levels
• Strong Teamwork.
• Being able to conclude the big picture out of details.
• Project Management.