QA Manager IBEX

QA Manager IBEX

Lonza

Visp, Switzerland

Do you believe you can make a difference? Do you thrive in an independent environment? Would you like to belong to an international, diverse, agile and flexible team whose passion is to get better and evolve together? Then we are looking for you.

Key responsibilities:

  • Owns all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. Represents QA in project/tech transfer organizations for new biotech manufacturing processes;
  • Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.;
  • Performs assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required;
  • Ensures all deviations are appropriately investigated and recorded, directs the investigations of customer product complaints and assures the completion of the appropriate documentation;
  • Identifies emerging QA relevant topics, communicates to the IBEX QA organization and works actively on their development into new or already established Quality and Compliance strategies and/or standards.

Key requirements:

  • Bachelor, Master degree or PhD in chemistry, biotechnology, life science or related field;
  • 5 years of experience in the GMP regulated pharmaceutical industry; preferable in a QA role;
  • General knowledge of manufacturing processes and analytical methods;
  • Experienced in the interaction with health authorities (Swissmedic, FDA etc.);
  • Fluency in English, willingto learn German;
  • Ability to oversee project execution to identify non-compliance from quality standards. Ability to prioritize and manage work to critical project timelines in a fast-paced environment;
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.

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© EuroJobsites 2022

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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