Quality Assurance Manager
Vor 2 Tagen
", "p": "As a Quality Assurance Manager at PAION Pharma GmbH, you will be responsible for ensuring that our contract manufacturers comply with EU-GMPs, international guidelines, and internal quality standards. Your tasks will include supporting analytical method transfer projects, qualifying and validating analytical methods, and ensuring batch documentation is properly controlled for compliance with EU-GMPs and the Marketing Authorization.
", "ul": [{"li": "Contribute to the improvement of our Quality Management System (QMS) for assigned products"}, {"li": "Responsible for handling deviations, CAPAs, laboratory investigations, customer complaints, and GDP incidents"}, {"li": "Perform GLP and GMP audits at contractor sites, prepare audit reports with CAPAs, and perform follow-up to ensure continual improvement in quality"}, {"li": "Accountable for improving our quality management system by performing internal audits, risk assessments, and root cause analyses"}, {"li": "Support QC teams in transfer of technology projects, such as analytical method transfer and production transfers to new sites"}, {"li": "Evaluate and coordinate product changes according to PAION Change Control procedures to ensure product/procedural compliance with registration, applicable regulations, and business expectations"}, {"li": "Manage supplier evaluation systems as required"}, {"li": "Review annual product reviews from manufacturing/packaging/QC-testing contractor sites and edit final PQRs according to PAION procedures"}, {"li": "Perform review of batch records and provide trending of results to support Certification of batches for designated products"}], "h3": "Your Profile
", "ul": [{"li": "MSc degree in life science, preferably pharmacy, biology, or chemistry"}, {"li": "5 years or more experience in the pharma industry GLP, GMP, and GDP environment"}, {"li": "Basic knowledge in Regulatory Affairs"}, {"li": "Fluent in German and English"}], "h3": "Why PAION Pharma GmbH?
", "ul": [{"li": "30 days vacation"}, {"li": "Short communication channels, open doors, and helpful, committed colleagues"}, {"li": "Flexible working hours with partial home office for a good work-life-balance"}, {"li": "State-of-the-art IT equipment with Dell equipment and Apple iPhones"}, {"li": "New office facilities with employee showers for athletes and underground parking spaces in Aachen in a very good location directly on the A44 freeway"}], "h3": "About PAION Pharma GmbH
", "p": "PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals. PAION Pharma GmbH is part of the Humanwell Healthcare Group."}
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