Jobs at West Pharma in Germany

• Program Activities:
• • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
  • Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
  • Report on the progress of projects; identify successes; and drive compliance.
  • Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
  • Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
  • Support design transfer activities for commercial and launch readiness and sustainment.
• Verification and Validation Activities:
  • Review and approve test method validations (protocols and reports).
  • Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
  • Facilitate and support the completion of projects up to and including PQ.
• Risk Management Activities:
  • Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
  • Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
• QMS Activities:
  • Support enterprise procedures updates that impact design and development activities.
  • Drive the closure of change controls and protocol non-conformance reports (PNRs).
  • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
  • Act as the interface between development teams and operational quality:
  • Perform first article component and product inspections
  • Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
  • Support the supplier selection process in accordance with West supplier management procedures.
  • Conduct and support internal and supplier audits, as required.
  • Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
  • Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
  • Actively engage in robust problem-solving to address quality issues.
• Metrology Activities:
  • Review and approve metrology data during OQ & PQ.
  • Support Quality Function Deployment activities (QFD).
• Compliance to all enterprise and local company policies and procedures.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Perform additional duties at the request of the direct supervisor.

• Bachelor's Degree in Chemistry, Engineering or Quality discipline required

• 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.

• Desirable: Regulatory Affairs experience

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
• Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
• Experience in Project Management
• Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Must be able to organise and prioritise tasks.
• Must have critical reading skills, maintain a high attention to detail and overall quality of work.
• Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
• Strong problem-solving skills, including root cause failure analysis methods.
• Must have excellent written and verbal communication skills.

• ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• 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.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• 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.

• Support of the payroll team in daily operations
• Assistance in the implementation of HR projects
• Maintenance of master data in the payroll program
• Creation of notifications and certificates of remuneration and insurance-relevant data for employees and external institutions
• Creation of personnel-related statistics
• Close cooperation with the HR team (HR Manager, HR Business Partner, etc.)

Advanced studies in the field of economics

• Structured and systematic working method
• Proficient use of MS Office
• Excellent German and good English skills, both written and spoken
• Quick comprehension skills
• High level of teamwork and communication ability

• Support of the payroll team in daily operations
• Assistance in the implementation of HR projects
• Maintenance of master data in the payroll program
• Creation of notifications and certificates of remuneration and insurance-relevant data for employees and external institutions
• Creation of personnel-related statistics
• Close cooperation with the HR team (HR Manager, HR Business Partner, etc.)

Advanced studies in the field of economics

• Structured and systematic working method
• Proficient use of MS Office
• Excellent German and good English skills, both written and spoken
• Quick comprehension skills
• High level of teamwork and communication ability

• Responsible for the payroll processing
• Ensure all new starters, leavers and promotions are processed accurately and timely
• Responsible for timely and professional resolution of any employee payroll related queries.
• Check all changes to tax details
• Be the main point of contact with the compensation team
• Complete welfare letters, bank forms, letters confirming service and any other payroll related letters.
• Support initiatives to increase employee understanding of payroll
• Support induction of new employees in relation to payroll and benefits
• Participate in internal audits as required
• Identify improvements and lead any compensation changes initiatives where required
• Support with Grants
• Prepare and deliver the annual Benefits Budget , including the proposal, costings and approval of same
• Lead improvement projects

• Bachelor's Degree in Business or Finance required
• Master's Degree in Business or Finance preferred

• Minimum 5 years’ experience in a finance or HR department and in processing complex payroll’s required

• Must have experience with computerised accounting systems and have a good knowledge of computer software MS office, Word, Excel.
• Must be able to organise and prioritise tasks for self
• Must be detail oriented and have strong organisational skills
• Experience in dealing with and manging employee queries in an efficient and professional manner
• Previous experience of working in a high-volume regulated manufacturing environment advantageous
• Be a team player as a key member of the HR Team
• Sets high standards of performance for self and others and assumes responsibility and accountability for successfully completing assignments and tasks
• Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.

Number of Direct Reports:Approximately 16
Contract Terms:Full-time, fixed term
asap

• Disciplinary and operational management of the shift as well as further development of employees
• Workforce planning and machine allocation
• Implementation of an open communication culture
• Monitoring and implementation of standards on topics such as quality, GMP, lean, regulations, documentation, and KPIs
• Production or processing of materials
• Supplying machines with raw materials
• Conducting a proper shift handover
• Involvement in projects (e.g., introduction of new technologies)
• Training and support of (new) employees

• Successfully completed vocational training

• Professional experience in a production environment, preferably in the pharmaceutical sector
• Leadership experience

• Good knowledge of SAP and MS Office
• Fluent German skills, both spoken and written; English skills are advantageous
• Successfully completed Lean and Six Sigma training (Yellow Belt) or willingness to complete the training
• Strong sense of safety, quality, and responsibility
• Structured planning and independent, goal-oriented working style
• High commitment and willingness to drive change
• Ability to work on shifts (3-shift system)