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
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