QC Analyst

3 weeks ago

Waterford, Waterford, Ireland CPL Full time
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:

- Review laboratory data in a timely manner to support batch release and stability programs.
- Verify results against trend limits and specifications; identify and escalate deviations or lab investigations.
- Conduct trending of data and track the frequency of Not Right First Time (NRFT) events.
- Provide QC and management support, maintaining clear communication across Quality and Production teams.
- Maintain, update, and issue control prints, methods, specifications, and SOPs in line with pharmacopoeial and regulatory requirements.
- Contribute to training of analysts in relevant techniques, SOPs, and updates.
- Ensure documentation and operations meet cGMP and GDP standards in a regulated environment.

Requirements:

- Minimum 3 years of QC or related experience in a regulated GMP environment.
- Empower software experience is essential – must be confident in using Empower for data review.
- High attention to detail and the ability to prioritize tasks to meet tight deadlines.
- Experience in identifying deviations and supporting lab investigations.
- Proficiency in quality systems and good understanding of regulatory compliance.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a collaborative team.

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