Senior Quality Manager (all gender)

YOU…

• are responsible for planning, oversight and management of the Control Procedure (CP) system within CQF in accordance with the GMP regulations and internal data management systems (e.g. CONDOR)
• evaluate and implement pharmacopoeial changes
• take over the change management/coordination of CPs with respect to compendial testing, internal testing and specification, etc.
• coordinate CP-related projects with internal and external business partners
• plan and implement periodic reviews of CPs within CQF in close collaboration with the QA and QC
• collaborate and optimize cross-functional activities regarding CPs (QSS, QC labs, etc.) and in other GMP work streams
• are leading projects to optimize workflows, authoring SOPs
• participate and preparate inspections and audits by customers and health authorities
• are the expert support for QC, Production, Registration and QA
• handling questions and requests (e.g. translations) from health authorities and Registration
• lead and support deviation investigations pertaining to control procedures
• support implementing CAPAs pertaining to control procedures (e.g. from OOS or deviation cases)
• take over the management of external laboratories in topics relating to CP updates
• will be responsible for general administrative and organisatorial tasks
• create and manage reports