Quality Assurance Specialist
vor 2 Monaten
About the Role
We are seeking a highly skilled Quality Assurance Specialist to join our HSE & Quality Culture and Compliance department in Bulle, Switzerland.
Key Responsibilities
- Actively participate in maintaining operational activities within the organization in compliance with GMP and UCB Quality standards.
- Manage the qualification of GMP purchased materials and associated vendors, service subcontractors (risk assessments, change controls, documentation, etc.).
- Manage and realize vendors' audits (questionnaires and on-site) planned for the year.
- Responsible for vendors' quality agreement update and creation; and ensure their successful and timely implementation.
- Responsible for the annual review of vendors.
- Responsible for the vendor's change notification process (analysis of the document, creation of report, and responsible for change control if any).
- Responsible for raw materials implementation & certification (testing & sampling) regarding quality aspects.
- Active participation in updating and maintaining vendor documentation in the electronic documentation system (documentation with expiry, documentation with periodic review, qualification documentation).
- Active participation in SAP configuration for vendors and purchased codes.
- Coordination of relationships with vendors to ensure effective following of deviations, change controls, investigations, incidents, complaints, CAPAs, etc.
Requirements
- Master's degree in Life Sciences.
- Extensive track record of 10 years in comparable positions within the pharmaceutical industry.
- Knowledge of SAP, LIMS (Laboratory Information Management System).
- Analytical knowledge.
- Demonstrated understanding of GMP environment.
- Very good communication, negotiation, convincing and presentations skills.
- Well-developed sense of discretion.
- Demonstrated ability to write-up scientific/technical documents.
- Ability to handle challenging situations, make decisions and work independently.
- Ability to coordinate multifaceted projects and to meet/respect critical deadlines.
- Sense of organization and priorities.
- Very good computer skills, including but not limited to, Microsoft Word - Microsoft Excel – Outlook.
- Languages: French and English (spoken and written).
Are you ready to make your mark for patients?
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