Senior QA Specialist - QA Projects 80-100% (f/m/d)

About the role

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 & cGMP compliance are implemented. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance A variety of benefits dependant on role and location The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits .

Responsibilities

• 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 like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Perform assessments for all product-related changes, assesses 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 the completion of the appropriate documentation.
• Identifie 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 - an advantage
• About Lonza
• Ready to shape the future of life sciences?

Benefits

Additional Information

Location: The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

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