
Senior Quality Assurance Specialist
18 hours ago
Job Title: Senior Quality Assurance Specialist
Job DescriptionWe are seeking a seasoned Senior Quality Assurance Specialist to ensure the quality and compliance of our manufacturing processes.
- Oversight of Manufacturing Processes:
- Review and approve executed batch manufacturing records (BMRs) and batch packaging records (BPRs) to ensure completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
- Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
- Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.
- Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
- Compile, review, and analyze electronic data for annual product quality review (APQR) reports, identify trends or recurring issues, and prepare remote review summaries for cross-functional teams.
- Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.
- Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, and track deviation trends for periodic reporting.
- Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria, and review CAPA closure documentation to confirm adequacy of evidence.
- Ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements.
- Participate in virtual inspections and audits, providing requested documentation and clarifications.
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