
Senior Commissioning and Qualification Specialist
5 days ago
Job Overview
We are seeking a skilled CQV Professional to join our team. The ideal candidate will have 3-4 years of experience in pharma CQV.
Key Responsibilities:
- Commissioning Activities:
- Author commissioning protocols for equipment and utilities, including installation checks and functional testing.
- Participate in FAT/SAT with engineering and OEMs.
- Author DQ, system impact assessment, and risk assessment documents in coordination with OEM.
- Qualification and Validation:
- Author, review, and execute qualification protocols for process equipment.
- Perform qualification according to regulatory requirements (FDA, WHO).
- Documentation:
- Have sound knowledge of good documentation practices and QMS throughout the CQV lifecycle.
- Coordinate with engineering, manufacturing, QA/QC, and IT teams for seamless project execution.
- Provide technical input during project planning and scheduling of CQV activities.
- Track and report progress of CQV milestones.
- Have good knowledge of project management and excellent communication and writing skills.
Requirements:
- Sound knowledge of QMS and good documentation practices.
- Excellent communication and writing skills.
- Good knowledge of project management.
Benefits:
- Achieve a successful career as a CQV professional.
- Gain valuable experience in the pharmaceutical industry.
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