Compliance Specialist | Compliance Specialist | M/W/D - Referenz 000993
consult16 GmbH
Job Summary
This role is for a Compliance Specialist at an internationally successful pharmaceutical company in Upper Swabia, Germany, initially on an 18-month contract. The specialist will independently create, coordinate, and manage Change Controls in Clinical Supply Biologics, acting as the primary contact for GMP topics and Change Controls within their area. Key responsibilities include active participation in cross-departmental compliance projects, supporting audits and inspections by preparing necessary documentation, and addressing compliance questions in both German and English. The ideal candidate will possess a degree in biotechnology, chemistry, or pharmacy with relevant experience, or a scientific background with extensive GMP experience. Strong communication, organizational skills, and a proactive, team-oriented approach are essential for success in this dynamic environment.
Required Skills
Education
Bachelor's degree in Biotechnology, Chemistry, or Pharmacy, or Master's degree in Biotechnology, Chemistry, or Pharmacy, or a completed scientific education.
Experience
- Several years of professional experience with a Bachelor's degree in Biotechnology, Chemistry, or Pharmacy
- Initial professional experience with a Master's degree in Biotechnology, Chemistry, or Pharmacy
- Long-term professional experience in a GMP environment (e.g., Production, Quality Assurance, Quality Control) with a scientific education
- In-depth knowledge of regulations concerning clinical sample manufacturing
- Strong assertiveness for goal-oriented completion of quality events
Languages
Additional
- Initial 18-month fixed-term contract. Location in Upper Swabia, Germany. Must be able to work with international partners and authorities.
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