Implementation Expert / Pharmaceutical Project Management | Implementation Expert (m/w/d) / Pharma Project Management
Akkodis Germany Tech Experts GmbH
Job Summary
This role involves supporting the implementation of pharmaceutical projects within a well-known Pharma and Biotech company, focusing heavily on documentation and quality compliance. The Implementation Expert will be responsible for creating and adapting implementation documents, such as User Requirements and Change Controls, in line with Quality Organization specifications and cGMP regulations. Day-to-day tasks include documenting and tracking meeting minutes, supporting various project workstreams, creating comprehensive project documentation (e.g., Scope Documents), and tracking/presenting project progress. Key qualifications include a Master's degree in a relevant engineering or life science field, at least five years of professional experience in cGMP-compliant pharmaceutical manufacturing, and strong knowledge of international Biologics manufacturing requirements and US/EU GxP regulations. This full-time position, located in the Rhine-Main region, offers hybrid work flexibility and is an excellent opportunity to contribute to critical projects within the Life Sciences sector.
Required Skills
Education
Master's degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, or comparable field
Experience
- Minimum 5 years of professional experience in cGMP-compliant manufacturing of pharmaceutical products
- Experience in the project environment of pharmaceutical facilities
- Professional experience with international requirements for active ingredient manufacturing (focus on Biologics)
- Experience in interface management
- Practical experience in Biologics manufacturing (advantageous)
Languages
Additional
- Not specified
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