Beschreibung
Project Lead - technology transfer sterile productsWe have an opportunity for an experience production expert to project manager technology transfer activities at site level to 3rd parties.
Major Accountabilities:
- Manages technical activities on site level for product tranfers (Process, technology, analytics, capacity, rescources)
- provides technical expertise
- Defines and monitors project scope, timing and progress
- Writes Manufacturing Process Transfer Documents (protocol, reports)
- Coordinates feasibility, regulatory and validation batches at site
- Supports continuous process and quality improvements
- Ensures inspection (PAI: Pre-Approval Inspection) readiness
- Initiates monitoring and CPV (continued process validation) phase
- 80% working time would be also ok if everything else is fine
Background (Musts)
- Minimum BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent
- 5+ years of relevant experience in pharmaceutical manufacturing
-project management skills and experience is a must
- Team Lead experience
- comprehensive knowledge in pharmaceutical technology
- deep knowledge in cGMP, HSE, Regulatory, etc.
- project management experience
- of competitive nature
- exercises good judgment
- used to make decisions
- fluent in English
- German desirable
Michael Bailey International is acting as an Employment Business in relation to this vacancy.