QA MANAGER – FILL & FINISH – ENGINEERING & OPERATIONS
Recrutis is recruiting for a leading international pharmaceutical company for a QA Manager specialized in Fill & Finish: Engineering & Operations.
Location: Yverdon-les-Bains, Switzerland
Collaborate with an innovative biotech organization expanding its aseptic manufacturing capabilities.
Responsibilities
* Lead QA aspects of engineering projects (aseptic filling line, isolators, cleanrooms).
* Ensure integration of GMP, Annex 1 and data integrity principles from design stage.
* Oversee qualification activities (FAT/SAT, IOPQ) and validate deliverables.
* Manage change controls and ensure traceability from design to execution.
* Drive Quality Risk Management throughout the project lifecycle.
* Ensure QA oversight of aseptic filling operations (Annex 1 compliance).
* Manage quality processes: SOPs, deviations, CAPAs, change controls, batch records.
* Act as primary QA contact during regulatory inspections and internal audits.
* Promote aseptic mindset and maintain sterility assurance standards.
* Analyze quality KPIs and lead continuous improvement initiatives.
Qualifications
* Proven experience in qualification, validation, and GMP operations.
* Significant experience in aseptic processes (isolator technology experience is a major asset).
* Strong experience in QA oversight of pharmaceutical manufacturing projects.
* Advanced knowledge of Eudralex GMP Annex 1 and Sterility Assurance concepts.
* In-depth knowledge of cGMP requirements and international regulatory standards.
* University degree in sciences (Pharmacy, Chemistry, Biotechnology, Engineering or related field).
* Excellent analytical and problem‑solving skills.
* Structured communication, both verbal and written.
* Fluent in French (written and spoken); English proficiency is an asset.
* Ability to work independently and collaborate effectively in multidisciplinary teams.
Leadership & Approach
* Leader with hands‑on approach.
* Systematic risk‑based approach.
* Ability to represent QA function with Health Authorities.
* Culture of compliance and continuous improvement.
What This Position Offers
* Strategic position in a leading biotech organization.
* Complete responsibility for Fill & Finish lifecycle (project + operations).
* State‑of‑the‑art technical environment (isolator, latest generation filling line).
* Direct impact on quality and commercial success.
* Yverdon-les-Bains location, exceptional living environment.
Seniority Level
Not applicable.
Employment Type
Full‑time.
Job Function
Quality Assurance.
Industries
Staffing and Recruiting.
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