Analytical Compliance Record Specialist m/f/d, Basel-Stadt Analytical Development is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of this work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. The QC-Section within the Analytical Development Department is responsible for the Release of Materials based on the GMP compliant execution of Analyses of Inprocess controls, raw materials, intermediates, APIs and Drug products.
Location: Basel
Duration: 12 months
Responsibilities: - Work in a modern quality control organization in compliance with cGMP regulations.
- Management of Compliance Records for the department, mainly Deviations, Changes and CAPAs
- Stakeholder management for the compliance record (including QA, Scientists, Senior Management)
- Facilitation and Documentation of Root Cause Analyses
- Active Participation in Quality Review Boards and other strategic and quality relevant governing bodies as needed
- Inspection Support, including preparation and presentation of records to internal and external auditors / health authority inspectors
- Critical evaluation of own work results
- Key role in ensuring an appropriate GMP standard in the department
- Scientific and regulatory documentation of the work done
Requirements - Advanced Degree: A university degree (Bachelor's, Master's, or higher) in a relevant Natural Science field (e.g., Chemistry, Pharmacy, Biology)
- Between 3 to 5 years of professional experience within a regulated pharmaceutical or biotech environment
- Proven, hands-on experience working under cGMP (current Good Manufacturing Practice) regulations is mandatory
- QMS Software: Proficiency in Veeva Vault or a comparable Quality Management System (e.g., TrackWise)
- Core Competencies: Demonstrated ability in managing compliance records, specifically Deviations, Change Control, and CAPAs
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coopers.chJob Profil (PD991I) - Life Sciences - Quality Management
- Basel-Stadt
- Contracting
- Vollzeit
- Immediately - 12 months after start date
- Compliance, GMP, CAPA
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Einfach "Jetzt bewerben" klicken, dann melde ich mich. Agnieszka Kawalec
Talent Acquisition Consultant
+41 41 632 43 54 agnieszka.kawalec@coopers.ch
