QA MANAGER - FILL & FINISH - ENGINEERING & OPERATIONS

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