To reinforce the Quality organization of a sterile manufacturing site, we are looking for a Quality Manager able to provide immediate, hands-on QA support on qualification, validation, supplier qualification, and GMP technical systems.
Key Responsibilities :
QA Oversight – Qualification & Validation
* QA support for equipment, utilities (HVAC, gases), and computerized systems qualification
* Review and approval of protocols, reports, and deviations
* Application of validation lifecycle principles
* QA support to aseptic process validation activities
Material & Supplier Qualification
* Establish and maintain material qualification processes (raw materials, primary packaging, consumables)
* Risk-based supplier qualification and oversight
* Management of supplier changes, deviations, and quality notifications
* Support to Quality Agreements management
QA Oversight – Maintenance & Calibration
* QA oversight of maintenance and calibration systems for GMP-critical equipment and utilities
* Review and approval of plans, records, deviations, and change controls
* Ensure GMP compliance and data integrity related to calibration status
Operational QA Support
* Deviation, investigation, CAPA, and change control management
* Technical risk assessments (equipment, utilities, materials)
* SOP updates and remediation activities linked to technical systems
Profile Requirements :
Education & Experience
* Scientific or Engineering degree (Pharmacy, Chemistry, Life Sciences, Engineering)
* 3–8 years of QA experience in GMP pharmaceutical environments
* Proven experience in sterile manufacturing
* Hands-on experience with qualification, validation, and technical GMP systems
Technical Expertise
* Strong knowledge of EU GMP, Annex 1 and Annex 15
* Solid understanding of validation lifecycle principles
* Experience in supplier qualification and quality oversight
* Strong knowledge of GMP maintenance and calibration requirements
Key Competencies
* Pragmatic, solution-oriented mindset
* Autonomous with fast integration capability
* Strong documentation and communication skills
* High GMP awareness and attention to detail
Position to be filled ASAP
Compensation starting from €40,000 gross per year
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