Key responsibilities:
* Management of authority inspections and customer audits at Drug Product Services (DPS) including
o participation in front office as host or scribe of inspectors/auditors
o acting as back office manager during inspections/audits
o preparation audits/inspections (including communication with customer)
o perform and supervise follow up of audits/inspections in audit management system (TrackWise)
o support SMEs during compilation of CAPA response plans
* Participation in inspection readiness program at Drug Product Services (DPS) sterile filling plant
* Coordination audit/inspection related activities internally
* Further on
o Supporting and executing GMP compliance activities e.g. Change requests, non-conformities, CAPAS, self-inspections, document management, local implementation of corporate documents
o Supporting establishment and maintenance of the Quality Management System at Drug Product Services (DPS)
Key requirements:
* Academic degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences or related field
* Significant working experience (>5 years) in Quality Assurance in pharmaceutical industries and GMP environment preferable in sterile manufacturing (e.g. QA oversight, QA operations) or analytical testing (QA for QC)
* Working experience includes participation in authority inspections (Swissmedic, FDA)
* Working knowledge in EU and US GMP regulations relevant for sterile manufacturing and analytical testing.
* Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. Document Management System) and processes for Drug Product manufacturing and analytical testing
* Excellent negotiation and communication skills as well as customer focus (intern/external)
* Professional working proficiency of written and spoken English and German
* Likes to work in an international team and intercultural environment
* Agile to adopt to new situations and moving targets in short period of time
* Self driven, independent
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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