Switzerland, Visp
Location: The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
We are looking for a Senior QA Specialist/QA Project Manager (f/m/d) for our BioAtrium organization. The QA Specialist, Project Manager specifies quality requirements for manufacturing processes and ensures that manufactured products comply with national and international requirements and cGMP standards over their entire life cycle. As a Quality and Compliance representative you will be a key member in cross‑functional project teams ensuring measures for product safety, product quality & cGMP compliance are implemented. You will have full QA oversight of a product and manage the project from a quality perspective.
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 dependent on role and location
The full list of our global benefits can also be found on https://www.lonza.com/careers/benefits.
What You Will Do
* Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for commercial supply. This includes oversight of QC / logistic / supply chain / manufacturing related activities
* Represent QA in project / tech transfer organizations for new biotech manufacturing processes
* Coordinate QA interests during the different project phases
* Make quality decisions for the respective projects in internal and external meetings
* Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
* 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
* Support the investigations of customer product complaints and assure the 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
* Involvement in generation of Annual Product Quality Reviews
* Participate and support regulatory inspections and customer audits
What we are looking for
* Academic degree in Biotechnology/ Biology/ Chemistry or related field
* Significant experience in the area of biopharmaceutical manufacturing, preferably in a QA function
* Strong background in cGMP and broad knowledge in biotechnological manufacturing processes, validation approaches and risk management
* Sound experience in representing Quality and Compliance in projects
* Good communication skills and experience in interaction with all kinds of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
* Experience in the use of the following systems would be preferred: TrackWise, LIMS, DMS and SAP
* Excellent written and spoken English is required; knowledge of German (written and spoken) is an advantage
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Reference: R72908
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