qa manager

Vor 2 Tagen

YverdonlesBains, Waadt, Schweiz Recrutis Vollzeit

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

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