Quality Assurance Manager Operations Drug Substance

Quality Assurance Manager Operations Drug Substance

Lonza

Visp, Switzerland

Key responsibilities:

  • Ensure the quality oversight of a new facility and drug substances produced therein;
  • Be involved in transfers of manufacturing processes; maintain contact with customers, facilitate discussions between customers and internal teams such as MSAT (Manufacturing Science & Technology), Manufacturing, Engineering and Quality Control;
  • Review and approve Discrepancy Records and Change Requests, manage the process for notifying the customer about discrepancies/change requests and assuring the customer’s feedback and relevant comments are addressed internally;
  • 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 and act as Owner of such documents;
  • Be involved in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness of the department.

Key requirements:

  • Bachelor in Biotechnology, Biology, Chemistry or other natural science;
  • Substantial experience in the area of biopharmaceutical manufacturing;
  • Broad knowledge of biotechnological manufacturing processes (especially microbiological biotech processes) as well as in cGMP;
  • Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies;
  • Strong team orientation and solution-oriented working approach;
  • Structured, focused and well-organized working attitude;
  • Fluency in English, German would be an advantage.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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