Key responsibilities:
Management of authority inspections and customer audits at Drug Product Services (DPS) including participation in front office as host or scribe of inspectors/auditors
acting as back office manager during inspections/audits
preparation audits/inspections (including communication with customer)
perform and supervise follow up of audits/inspections in audit management system (TrackWise)
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 Supporting and executing GMP compliance activities e.g. Change requests, non-conformities, CAPAS, self-inspections, document management, local implementation of corporate documents
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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