Beschreibung
The Quality Manager (QAM) is part of the process-transfer project team and provides all quality and compliance related guidance and support. Approve and maintain quality oversight with respect to supply of materials from global external suppliers and CMOs of chemicals and Drug Substances and to ensure that all aspects of the relationship and management thereof, are in compliance with cGMP’s, regulatory requirements, the Quality Manual and Pharma industry practices.Activities are:
• Management of Change Controls (Agile)
• Review and approval of transfer protocols
• Support of supplier qualification/certification
• Preparation and alignment of Quality Assurance Agreement (QAA)
• Review and approval of Master Batch Records, validation protocols & reports, Quality Risk Assessments, Testing Monographs etc.
• Supporting Supplier Audits and Following up on Audit CAPA activities
• Review of ICH M7 questionnaires
• Management of Deviations / OOS results (TrackWise/AQWA)
• Assuring cGMP compliance of DS manufacturing, testing and release
• Regulatory Compliance checks
• Review of manually generated CoAs to support submission activities
• Review of approval of SAP changes to inspection plans
• Review and approval of registration modules as required for submissions (Subway)
• Drafting and approval of different statements (for registration and material qualification purposes)
• Generation of responses to Health Authority queries
• Site visits if required
• Preparation of APR / PQR
• Creates/Review/approval of supplier annual monitoring reports
• Maintenance of compliance systems e.g. supplier master list, GMP certificate database
• Transfer of suppliers’ QA oversight to ESO QA Managers after project is completed.
Preferred background:
• Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related science
• Fluent in English -spoken and written
• Minimum 3 years of experience in in the pharmaceutical industry.
• Minimum 3 years of experience in operational quality assurance. Good knowledge of cGMP requirements for major regulated markets (EU, US).
• Project work experience required
• Experience with IT tools like Trackwise (AQWA), Subway, Agile desirable