
Senior Quality Assurance Manager
11 hours ago
Commissioning and Qualification (CQV) Specialists are in high demand to lead projects and ensure compliance with regulatory standards. We are seeking a seasoned professional with over 10 years of experience in the pharmaceutical, biotech, or medical device industries.
Key Responsibilities:
- Develop and execute CQV strategies for capital projects, including facilities, utilities, equipment, and automation systems.
- Prepare, review, and finalize C&Q documentation, including URS, FAT, SAT, IQ, OQ, PQ protocols, test scripts, and reports.
- Ensure adherence to cGMP, FDA, EMA, ISPE Baseline Guides, ASTM E2500, and ICH guidelines.
- Lead commissioning activities, including system walkdowns, punch-list management, testing, and issue resolution.
- Collaborate with cross-functional teams (Engineering, QA, Validation, Operations, Automation) to drive project success.
- Implement risk-based approaches (RBV/CQV) to optimize CQV processes.
Requirements:
- 10+ years of experience in Commissioning and Qualification.
- Proven track record of leading complex CQV projects.
- Excellent communication and project management skills.
- Knowledge of cGMP, FDA, EMA, ISPE Baseline Guides, ASTM E2500, and ICH guidelines.
What We Offer:
- Competitive compensation package.
- Opportunities for professional growth and development.
- Collaborative work environment.
As a Commissioning and Qualification Specialist, you will be responsible for ensuring that our facilities, utilities, equipment, and systems are properly qualified and commissioned. If you have a passion for ensuring quality and safety, we encourage you to apply for this exciting opportunity.
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