Contract Type: Temporary Fixed-Term Contract (2-Year Assignment / 100%)
Your Responsibilities
- Documentation & Batch Review: Perform initial intake and completeness checks of manufacturing and packaging records for investigational medicinal products (IMPs), compiling all required documentation packages to support QA batch release.
- Quality Event Management: Log, track, and document deviations, logistical temperature excursions, and product complaints. Review root cause investigations from external partners for completeness and plausibility.
- Partner & Interface Coordination: Actively communicate with external contract manufacturers (CMOs), track deadlines for quality requests, and support the maintenance of Quality Agreements as well as the preparation of quality KPI reports.
- System & Data Maintenance: Maintain quality data in electronic document management systems (eDMS/eQMS) and ERP platforms, keep tracking tools updated, and ensure all records remain in an inspection-ready state at all times.
Your Profile
- Education: Degree (Bachelor’s or higher) in Life Sciences, Pharmacy, Chemistry, or a related discipline.
- Professional Experience: 1 to 3 years of relevant hands‑on experience in Quality Assurance (QA), Quality Control (QC), or pharmaceutical manufacturing.
- GxP Knowledge: Solid understanding of cGMP and GDP principles, alongside practical experience reviewing GMP documentation and deviation reports.
- IT Skills: Familiarity with electronic quality systems (eDMS/eQMS) or ERP software (e.g., SAP) is an advantage.
- Working Style: Highly structured approach with strong attention to detail and the ability to identify quality risks and elevate them appropriately.
- Languages: Business fluent in English (written and verbal); German and/or French skills are a plus.
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Kontaktdaten:
Skilled Recruitment Solutions GmbH Recruiting-Team
