Specialist, Pharmaceutical Production Documentation | Mitarbeiter (m/w/d) für die pharmazeutische Produktionsdokumentation
Orizon GmbH NL Ingolstadt
Job Summary
This role seeks a dedicated Specialist in Pharmaceutical Production Documentation to ensure rigorous quality assurance and compliance within an innovative global healthcare company focused on developing new treatments for serious diseases. Day-to-day responsibilities involve meticulous review and validation of critical manufacturing data, including checking data transfers from paper to electronic systems, assessing the completeness and plausibility of entries, and verifying IPK results against strict regulatory guidelines. The specialist will also control and evaluate machine logs and process graphics to confirm correct process flow, review weighing and yield determinations, and manage documentation related to disturbances and alarms. Key qualifications include formal training in a pharmaceutical profession (such as a Pharmaceutical Technician) and proven experience in creating or reviewing pharmaceutical documentation. Candidates must possess strong GMP knowledge, technical understanding of manufacturing processes, and fluent German skills (B2 minimum) to succeed in this highly regulated environment.
Required Skills
Education
Training in a pharmaceutical profession (e.g., Pharmaceutical Technician or Certified Pharmacy Assistant - PTA). Knowledge of the Pharmacopoeia is advantageous.
Experience
- Experience with the creation or review of pharmaceutical documentation
- Theoretical knowledge in drug manufacturing
- Technical understanding of manufacturing processes
- Ideally, professional experience in a pharmaceutical production facility
Languages
Additional
- Not specified