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

pSenior QA Specialist - QA Projects 80-100% (f/m/d) /p pbLocation: /bThe actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. /p h3The role: /h3 pThe 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. /p h3What you will get: /h3 pAn agile career and dynamic working culture /p pAn inclusive and ethical workplace /p pCompensation programs that recognize high performance /p pA variety of benefits dependant on role and location /p pOwn 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. /p pResponsible 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. /p pPerform assessments for all product-related changes, assesses relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required. /p pEnsure all deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation. /p pIdentifie 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. /p pTrain 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. /p h3What we are looking for: /h3 pAcademic degree in Chemistry/ Biotechnology/ Life Science or any related field. /p pSolid experience in the GMP regulated pharmaceutical industry is required; preferably in a QA role. /p pGeneral knowledge of biopharmaceutical manufacturing processes and analytical methods. /p pExperienced in the interaction with health authorities (Swissmedic, FDA etc.). /p pAbility 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. /p pStructured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive. /p pStrong team orientation with excellent verbal, written and interpersonal communication skills. /p pBusiness fluent English is required, good German skills - an advantage /p h3About Lonza /h3 pAt 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. /p pInnovation 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. /p ul liTake ownership, step forward, and enjoy meaningful responsibility /li liLove solving problems and thrive in a complex, fast-moving environment /li liAre curious, always looking to learn and improve /li liWork collaboratively, contributing to something bigger than yourself /li liAre motivated to make a difference through work that impacts customers and their patients /li /ul h3Why Lonza: /h3 pWe are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. /p pbWe are the makers of the medicines of tomorrow. /b /p #J-18808-Ljbffr