Description
QA / QC Specialist with profound GMP knowledge wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- Degree in scientific, laboratory, manufacturing or relevant discipline (advanced technical college, BA/BS or equivalent)
- 5+ years of experience in a corresponding line unit function (e.g. laboratory, manufacture, packaging, IT)
- Solid knowledge of relevant GMPs, working knowledge of safety and environmental regulations and guidelines
- Sound scientific, technical and regulatory knowledge in a specific area
- Good understanding of drug development, proven ability to analyze and evaluate GMP compliance
- Negotiation and communication skills to address GMP related questions with the line unit experts, in order to maintain GMP records in a compliant status
- Languages: fluent English both written and spoken
Your tasks:
- Supervising 0-3 direct/indirect reports or a team
- Reviewing of GMP relevant documents for compliance with SOPs across several customer groups (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, etc.).
- Performing review and approval of GMP relevant documents derived from approved sources (e.g. analytical working sheet templates, specifications)
- Reporting complex deficiencies in GMP documents to supervisor, suggesting actions and supervising agreed follow-up
- Acting as contact person for QA questions of quality relevant electronic systems (e.g. IMOS, GLIMS, TQW, QP database, TEDI, ESOPS, Pathlore) and/or as a contact person to the needs of the line unit
- Writing and completing GMP relevant documents in own area of responsibility (e.g CoAs, CoCs, BRR sheets, test scripts, SOPs with extended applicability)
- Performing statistical interpretation of trending data collected by QA (e.g. in TQW or audit database)
Start: ASAP
Duration: 8MM+
Location: Basel, Switzerland
Ref.Nr.: BH10692
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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