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Project Lead- Technology Transfer
Eingestellt von Michael Bailey Associates - Zurich
Projektbeschreibung
Project Lead - technology transfer sterile products
We 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.
We 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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges