Senior Compliance Specialist | Compliance Senior Specialist | M/W/D – Referenz: #001135
consult16 GmbH
Job Summary
As a Senior Compliance Specialist for an internationally successful pharmaceutical company in Upper Swabia, you will hold a central responsibility within a GMP-regulated environment. Your day-to-day activities involve securing regulatory requirements and managing complex compliance topics at the intersection of specialized departments and quality assurance. You will oversee the document management of critical GMP documents, including Out-of-Specification (OOX) results, Corrective and Preventive Actions (CAPA), effectiveness checks, deviations, and risk analyses. Additionally, you will actively support audits and inspections by preparing necessary documentation and presentations. This role is ideal for professionals who thrive in highly regulated settings and enjoy coordinating cross-departmental compliance initiatives. The position offers a unique opportunity to work within a technologically innovative pharmaceutical environment on a fixed-term basis until mid-2027, providing a stable yet dynamic platform to apply deep regulatory expertise.
Required Skills
Education
University degree (PhD, Diploma, Master, or Bachelor) in Biochemistry, Biopharmacy, Biology, Chemistry, or Pharmacy; alternatively, a Master Craftsman qualification in a natural science field (e.g., Pharmacy Master) with relevant experience.
Experience
- Several years of professional experience in biotechnical production, quality assurance, quality control, or a GMP/compliance environment
- Professional experience in managing complex GMP documentation such as CAPA and risk analyses
- Experience in coordinating cross-departmental compliance topics and interfacing with internal and external stakeholders
- Proven track record in supporting audits and inspections within the pharmaceutical industry
Languages
Additional
- The position is initially fixed-term until June 30, 2027. Candidates must be able to work within the framework of temporary employment (ANÜ). High intercultural competence and presentation skills are required.
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