Quality Assurance Manager Operations Drug Substance

Switzerland, Visp

Randstad (Switzerland) AG is currently seeking a QA Manager Operations Drug Substance in Visp, Switzerland.

In this role, you will be a member of a small QA team that will ensure the quality oversight of a new facility and drug substances produced therein. You will be involved in transfers of manufacturing processes, review and approve manufacturing SOPs (Standard Operating Procedures) and recipe, release or reject drug substances on behalf of the Responsible Person.

Key responsibilities:

  • Be involved in all facility start-up activities as well as process transfers
  • Responsible for defining the bill of material and be involved in all activities required to qualify raw materials
  • Facilitate discussions within internal cross-functional teams such as MSAT (Manufacturing Science & Technology), Manufacturing and Quality Control
  • Review and approve manufacturing recipes
  • Perform batch record reviews in the Manufacturing Execution System
  • Review and approve Discrepancy Records and Change Requests
  • Support the definition of preventive and corrective measures (CAPAs), approve them and track their timely implementation and effectiveness
  • Release Drug Substance batches
  • Review and approve SOPs and project related documents; support and approve quality risk analysis (e.g. FMEA)
  • Write or revise SOPs in your area of expertise
  • Support cGMP training programs to ensure staff is trained
  • Be involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department
  • Actively support the Quality culture as a role model

Key requirements:

  • Bachelor in Biotechnology, Biology, Chemistry or other natural science; Master or PhD would be preferred
  • Profound working experience in the area of biopharmaceutical manufacturing
  • Knowledge of biotechnological manufacturing processes (especially microbiological biotech processes) as well as in cGMP
  • Good communication skills
  • Strong team orientation
  • Structured, focused and well-organized working attitude, solution-oriented
  • Open-minded for new ideas and suggestions
  • Fluency in English, German would be an advantage
Reference: R30559
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