Pharmaceutical Production Documentation Specialist | Fachkraft für die Pharmazeutische Produktionsdokumentation (m/w/d) mit langfristiger Perspektive
TYC Personalmanagement Gerlinde Tyc
Job Summary
This specialist role involves ensuring meticulous quality and compliance for batch documentation within pharmaceutical production. Day-to-day tasks include reviewing completed batch records, verifying data transfers between paper and IT systems, and checking the completeness and plausibility of all entries. You will assess In-Process Control (IPC) results, control machine and equipment documentation (logs, process graphics) for correct process flow, and verify weights, balances, and yield determinations according to strict specifications. Furthermore, the role requires evaluating and commenting on disturbances, alarms, and quality-relevant diagnoses, and supporting the design of new manufacturing protocols. Key requirements include professional training in a pharmaceutical field (e.g., Pharmaceutical Technician or Assistant), experience reviewing pharmaceutical documentation, and strong theoretical knowledge of drug manufacturing. Candidates must possess GMP knowledge, technical process understanding, and excellent German language skills (minimum B2), ideally complemented by SAP and MS Office proficiency.
Required Skills
Education
Training in a pharmaceutical profession (e.g., Pharmaceutical Technician or Pharmacist Assistant)
Experience
- Professional experience with the creation or review of pharmaceutical documentation
- Theoretical knowledge in the field of drug manufacturing
- Technical understanding of manufacturing processes
- Ideally, experience gained in a pharmaceutical production operation
Languages
Additional
- Willingness for 2-shift work (normally day shift); Reliable, responsible, careful, and flexible working style; High team and interaction capability.
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