Senior Quality Assurance Manager

☞ Capgemini Engineering

View: 144

Update day: 24-04-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Information Technology Services Computer Software Mechanical or Industrial Engineering

Position: Mid-Senior level

Job type: Full-time

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Job content

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, Lausanne and Geneva.
Your role
  • Ensure that Drug Substances & products (DS and DP) are manufacturing in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.
  • Responsible for deviations & CAPA Management, complaints and change controls with process and product impact.
  • Understand and support review of investigations, root cause analysis and review
  • Internal Audits / external Audits support coordination.
  • GMP document review and approval: APQRs, Protocols/ Validation and Qualifications Reports, SOPs, BMR, work instructions.
  • Oversee GDP related activities throughout the product supply chain
  • Maintain and extend technical and professional competence in support prior to the QP batch certification and disposition.
  • Support Quality Systems and Compliance on continuous improvement of the Quality Management System (QMS), support quality management review processes, annual product quality reviews, overall inspection readiness and state of control.
  • Establish and maintain effective communication with clients to match internal and external expectations.
  • Interact with Health authorities as it pertains to licenses and regulatory activities.
Your profile
  • Master’s degree in Pharmacy, chemistry, biotechnology or in Regulatory Affairs
  • 10 years of experience in the biotechnology or pharmaceutical industries
  • Experience in Quality Assurance & Quality Control activities in within life sciences multinationals
  • Thorough knowledge in cGMP global regulatory requirements, quality systems and importation requirements.
  • Proven track record in interacting with QA, QC and regulatory teams and successful health authority inspection experience.
  • Proven ability to lead and manage projects/teams of significant scope and complexity, directly or indirectly, while meeting all deliverables and timelines.
  • Excellent working knowledge, understanding and experience with practical implementation of local laws, FDA and EMA regulations and industry guidelines including data integrity, computer system validation and electronic records and signature requirements.
  • Fluency in English, German a plus.
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. 
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Deadline: 08-06-2024

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