We are currently seeking an experienced QC Data Reviewer to join our client's Quality Control team. This role plays a crucial part in supporting batch release and stability programs by ensuring data integrity, compliance, and effective interdepartmental collaboration.
Key Responsibilities:
1. Review laboratory data in a timely manner to support batch release and stability programs.
2. Verify results against trend limits and specifications; identify and escalate deviations or lab investigations.
3. Conduct trending of data and track the frequency of Not Right First Time (NRFT) events.
4. Provide QC and management support, maintaining clear communication across Quality and Production teams.
5. Maintain, update, and issue control prints, methods, specifications, and SOPs in line with pharmacopoeial and regulatory requirements.
6. Contribute to training of analysts in relevant techniques, SOPs, and updates.
7. Ensure documentation and operations meet cGMP and GDP standards in a regulated environment.
Requirements:
8. Minimum 3 years of QC or related experience in a regulated GMP environment.
9. Empower software experience is essential – must be confident in using Empower for data review.
10. High attention to detail and the ability to prioritize tasks to meet tight deadlines.
11. Experience in identifying deviations and supporting lab investigations.
12. Proficiency in quality systems and good understanding of regulatory compliance.
13. Strong communication and interpersonal skills.
14. Ability to work independently and as part of a collaborative team.