Pharmaceutical Production Documentation Specialist | Mitarbeiter für die pharmazeutische Produktionsdokumentation m/w/d
M. Schormair GmbH
Job Summary
This role is for a Pharmaceutical Production Documentation Specialist dedicated to ensuring regulatory compliance and data integrity within the manufacturing process. Day-to-day responsibilities include meticulously reviewing data transfers between paper and electronic systems, verifying the completeness and plausibility of entries, and checking In-Process Control (IPC) results against specified requirements. The specialist will control and evaluate machine and equipment documentation, assess process flow correctness, and review critical parameters like weighings, balances, and yield determinations. A key function involves evaluating disturbances, alarms, and quality-relevant diagnostics, providing clear commentary, and supporting the design of manufacturing protocols. Candidates must possess a pharmaceutical qualification (e.g., Pharmacist or PTA), practical experience in pharmaceutical documentation, theoretical knowledge of drug manufacturing, and technical process understanding. Familiarity with MS Office and ideally SAP is required. This permanent position offers above-tariff pay and long-term stability in a critical quality assurance function.
Required Skills
Education
Training in a pharmaceutical profession (e.g., Pharmacist or Pharmaceutical Technical Assistant / PTA)
Experience
- Experience with the creation or review of pharmaceutical documentation
- Theoretical knowledge in the area of drug manufacturing
- Technical understanding of manufacturing processes
- Ideally, experience gained in a pharmaceutical production operation
Languages
Additional
- Reliable, responsible, meticulous, and flexible work style coupled with high team and interaction capability.
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