guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented
Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality
Act as an internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products
Coordination and controlling of all GMP relevant documents with regard to manufacturing process, quality control and quality assurance
Support/perform the initiation, coordination and evaluation of new product introductions and product changes
Maintain the regulatory compliance of suppliers with EMA authorities
Review and Authorize Master Documents to assure regulatory compliance on the supplier’s level
Support the negotiation, preparation and approval of new QTA’s
Support preparation and execution of regular audits/technical visits to the entrusted vendors
Support the initiation & Oversight on PQRs for medicinal products manufactured by 3rd parties
Support the necessary investigation and closure of deviations

Bachelor’s degree in Pharmaceutical/Natural/Engineering science or related field
3+ years’ experience in quality control / analysis, production and / or quality assurance
Must have working knowledge of cGMPs and applicable international regulations/guidelines
Strong computer skills including MS Office, TrackWise and SAP
Good communication skills and resilience
Good command of the written and spoken English language

Quality Operations Manager – ExM

Key skills