Compliance Specialist (GMP/Quality Services/Biopharma) | Compliance Specialist (m/w/d) in Vollzeit / GMP / Quality Services / Biopharma
expertum GmbH
Job Summary
This role involves ensuring strict regulatory adherence within a leading pharmaceutical company, focusing heavily on GMP (Good Manufacturing Practice) compliance. The specialist will be responsible for processing and coordinating cross-functional Change Controls and material qualifications for packaging materials and disposables. Day-to-day tasks include coordinating the creation and processing of GMP-relevant documentation, CAPAs (Corrective and Preventive Actions), deviations, and internal regulations. You will communicate decisions within the department and present findings during audits, inspections, and supplier inquiries in both German and English. Key requirements include a natural science degree (or equivalent long-term professional experience), excellent GMP knowledge, strong regulatory understanding, and the ability to work precisely, independently, and assertively. This attractive position offers a hybrid work model, allowing 2-3 remote days per week after initial on-site training.
Required Skills
Education
Completed natural science degree (Bachelor or Master) in Chemistry, Biology, Biochemistry, Biotechnology, or Pharmaceutical Technology, or relevant vocational training
Experience
- Initial professional experience (for Bachelor's degree holders)
- Long-term experience in manufacturing sterile medicinal products (if substituting a degree)
Languages
Additional
- Willingness to work in a hybrid model (2-3 remote days per week possible after on-site training); Location: Biberach an der Riß
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