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2 days ago
We are seeking a highly skilled professional to fill the role of Quality Compliance Specialist.
- The ideal candidate will have a strong background in computer system validation and quality compliance.
Job ResponsibilitiesKey Functions:
- Conduct thorough reviews of computer systems to ensure they meet regulatory requirements.
- Develop and implement quality control strategies to ensure compliance with FDA regulations.
- Analyze data to identify trends and areas for improvement.
- A minimum of 5-8 years of experience in Computer System Validation/Quality Compliance in a regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Strong knowledge of FDA regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in Electronic Document Management systems and Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
- Familiarity with fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Demonstrated ability to work independently and as part of a team to achieve project goals.
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