Recrutis
Yverdon-les-Bains, Vaud, Suisse (Sur site)EnregistrerPostuler
Yverdon-les-Bains, Switzerland
RECRUTIS is recruiting for a leading international pharmaceutical company a QA Manager specialized in Fill & Finishing: Engineering & Operations.
THE CONTEXT
You will join an innovative biotech organization expanding its aseptic manufacturing capabilities. This key position will cover the entire lifecycle: from project phase (qualification, commissioning) through to routine GMP operations.
Your Main Responsibilities
Project Phase Design, Qualification & Commissioning
* 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
Operational Phase Aseptic Manufacturing Operations
* 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
Required Profile
Experience & Technical Expertise
* 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
Education & Skills
* 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