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; 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
Health insurance
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.
Lonza · Switzerland