Vacancy caducado!
- Min 10-15 years direct experience in validation/qualification of equipment used in the aseptic operations
- Proven Technical writing capabilities
- Ability to independently prepare a regulatory package on the IQ/OQ and PQ of process or equipment with little guidance
- Ability to execute and troubleshoot and provide direction and remediation solutions during execution issues
- Min 10-15 years in GMP compliance roles with significant experience in the area of operations and operations process excellence
- In depth understand of the GMP regulations and how to apply them - Proven skills around operational excellence with knowledge in
- Skilled in problem solving and the use of standard tools for process optimization - LEAN sigma trained greenbelt preferred
- Proven experience in deviation management with excellent oral and written skills
- Critical thinker who drives options on design based on data analysis
Vacancy caducado!