Quality Assurance Manage

m/f/d,

You will support and oversee the end to end cGMP activities in implementation of Annex 1 requirements at the Clinical Supply Centre Basel, take care that the Right to Operate can be maintained by ensuring that quality and compliance requirements according to Health Authority expectations and Company Standards for IMP products are given after the successful implementation of Annex 1.

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

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