The purpose of this role is to manage quality assurance activities within the manufacturing process units to ensure the compliance with the required documentation and quality systems.
• Compile Annual Product Reviews (APRs)/Product Quality Reviews (PQRs) in accordance with GMP-requirements. Ensure that related follow-up activities are defined, carried out and reported.
• Lead the evaluation and implementation phases of change requests,
• Maintain and ensure general QA-oversight of all activities of the related Process Units (PUs) (with regard to products and general Quality Systems) and ensure general GMP-Compliance.
• Review and approve Master Batch Records, Standard Operating Procedures (SOPs), Transfer Protocols, Reports and other GMP-relevant documents.
• Lead, oversight and participate in self-inspections, and support inspections from health authorities on site.
• Initiate and implement quality improvement projects, conduct QA walkthroughs...etc
* reviewed and prepare in time, change requests processed in time and if required quality, self-inspections, reports.
• review deviations triggered by information and documents provided
Prior experience in quality assurance/ quality control or manufacturing area of pharmaceutical products
Fluent in English and German languages
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.