QA Process Validation Manager

☞ Capgemini Engineering

View: 146

Update day: 18-03-2024

Location: Bern Bern BE

Category: High Technology Mechanical / Technical Electrical / Electronics Consulting / Customer Service Production / Operation

Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Responsibilities

  • Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation.
  • Ensures that internal/external GMP standards and regulatory requirements related to process validations are adhered to in projects.
  • Participates in or moderates cross-functional Risk Assessments to define the scope of validation/study activities.
  • Leading the process validation teams including communication with customers.
  • Issues, reviews or approves SOPs and project related documents.
  • Acts as author of parts of Annual Product Quality Reviews.

Requirements

  • M. Sc. Degree in a Life Science discipline (PhD in Biotechnology or Chemistry, preferred).
  • 3+ years of experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit.
  • Strong background in cGMPs.
  • Broad knowledge in biotechnological manufacturing processes, validation approaches and risk management.
  • Sound experience in representing Quality and Compliance in projects.
  • Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.).
  • Excellent verbal, written and interpersonal communications skills.

If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.

Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.

Capgemini Engineering is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.

Our offer

  • A permanent contract with the leader in innovation and high-tech engineering consulting.
  • A multi-stage model with career opportunities through specialization prospects with over 250’000 consultants around the world and a Group revenue of EUR. 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
  • In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
  • 30% to 70% remote work in agreement with your line manager and client needs.
  • Trust-based managerial culture.
  • Team rituals and get togethers.
  • Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.
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Deadline: 02-05-2024

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