Quality Assurance Manage (m/f/d)

Start date: Immediately

Duration: 1 year/possible extension

Workload: 100%

Location: Basel

Responsibilities:

• Support and drive implementation of Annex 1 requirements during implementation in the Clinical Supply Centre for sterile Drug Product (Parenterals) within IMP Switzerland
• Responsible to represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland
• Maintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
• Support and collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland
• Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. SOPs, qualification, validation documents)
• Partner with all stakeholders within the Clinical Supply Centre as well as with Technical Development and provide guidance to ensure successful delivery of the Annex 1 implementation goals
• Support your area of responsibility at HA inspections and internal audits

Requimements:

• BS/MS/PhD Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalent
• Fluent German is mandatory
• Min. 2-5 years experience in a GMP regulated environment and with Quality Systems, Quality assurance and OT
• Experience in Quality Risk Management as well as in performing risk assessments (e.g. FMEA)
• Experience in Qualification / Validation as well as all all activities around parenteral manufacturing