Must have pharmaceutical manufacturing experience.
Project Duration – 18 months approximately.
Related Experience: 15+ Years
Education: Bachelor’s Degree in Science or Engineering
- C&Q activities leadership, such as coordination, scheduling and follow-up activities with system users, supporters, SMEs, and others.
- Develop with the Sr Verification Engineer the project C&Q strategy as per site procedures.
- Generate project related Change Controls and closure.
- Generate Project C&Q Plan (PCQP).
- Manage site electronic platforms as per role requirements (PDOCs & QTS).
- C&Q knowledge of requirements on manufacturing process equipment, automation, facilities, and utility systems.
- Able to discuss issues with QA, EHS, Manufacturing and Technical Services to reach sensible agreement.
- Provide technical direction to all contractors/resources supporting C&Q activities.
- Strong interpersonal, teamwork and problem-solving skills.
- Coordination of C&Q documentation revision, organization, approval, and filing.
- Be active in the resolution of problems or deviations found during the qualification activities.
- Determine interactions between qualification of systems.
- Fully Bilingual: verbal and written.