Inserat online seit: Veröffentlicht vor 13 Std.
Aufgaben der Stelle
PbLocation: /b the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. /ppbWhat you will get: /b /plipAn agile career and dynamic working culture /p /lilipAn inclusive and ethical workplace /p /lilipCompensation programs that recognize high performance /p /lilipA variety of benefits dependant on role and location /p /lipThe full list of our global benefits can be also found on /pppbbWhat you will do: /b /b /p /plipEstablish Quality Agreements (QAA) in close collaboration with Drug Product Services DPS in Basel / Stein and LONZA Drug Substance (DS) sites (e.g. Slough / Visp). /p /lilipAct as QA representative in Project teams and represent QA in customer meetings during Technical Transfer. /p /lilipAct as QA contact for specific projects and realize the interface for DRs and CRs with the customer (routine follow-up’s). /p /lilipAct as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations. /p /lilipOrganize customer audits together with the Visp Compliance team and DPS Basel functions. /p /lilipSupport and approve project / product specific risk assessments or regulatory specific risk or gap assessments. /p /lilipReview and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc. /p /lilipWork closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI). /p /lilipSupport general organization of inspections (front / back office). /p /lilipRepresent Drug Product QA topics during regulatory inspections. /p /lilipSupport continuous improvement programs to establish an effective Quality Management System for Visp DPS. /p /lilipRepresent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes. /p /lilipAssess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs. /p /lipbWhat we are looking for: /b /plipUniversity degree or equivalent in Chemistry / Biology / Biotechnology or a related field /p /lilipLong-term experience working in the GMP environment of the pharmaceutical industry /p /lilipExperience working in a QA department would be an advantage /p /lilipBusiness fluent English is required, German language skills are an advantage /p /lipbAbout Lonza /b /ppAt 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. /ppInnovation 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. /ppbReady to shape the future of life sciences? Apply now. /b /p Reference: R76076
