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The Senior QA Specialist (f/m/d) for QA Projects specifies quality requirements for manufacturing processes and cGMP standards over their entire life cycle. As a Quality and Compliance representative, he/she will be a key member in cross-functional project teams ensuring measures for product safety, product quality and cGMP compliance are implemented.

Tasks

  • Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply.
  • Represent QA in project/tech transfer organizations for new biotech manufacturing processes.
  • Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols and Reports.
  • Perform assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.
  • Ensure all deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure completion of the appropriate documentation.
  • Identify emerging QA relevant topics, communicate to the IBEX QA organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards.
  • Train and mentor junior Lonza employees to better accomplish and perform in their duties as Quality professionals.
  • Support cGMP training programs to ensure staff is being trained.

Requirements

  • Academic degree in Chemistry, Biotechnology, Life Science or any related field.
  • Solid experience in the GMP regulated pharmaceutical industry is required, preferably in a QA role.
  • General knowledge of biopharmaceutical manufacturing processes and analytical methods.
  • Experienced in the interaction with health authorities (Swissmedic, FDA etc.).
  • 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.
  • Strong team orientation with excellent verbal, written and interpersonal communication skills.
  • Business fluent English is required; good German skills are an advantage.

Benefits

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • A variety of benefits dependent on role and location.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.
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