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Quality Assurance Specialist
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The role of Quality Assurance Specialist is pivotal in ensuring the quality and compliance of sterile injectable manufacturing processes.
- Review and verify executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) to ensure completeness, accuracy, and compliance with regulatory requirements.
- Coordinate with cross-functional teams to resolve discrepancies or missing documentation before batch release.
- Monitor electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results to identify trends or recurring issues.
- Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
- Analyze electronic data for Annual Product Quality Review (APQR) reports, prepare remote review summaries for cross-functional teams, and identify areas for improvement.
- Review 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.
- Review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
- Maintain close coordination with cross-functional teams to ensure timely resolution of documentation and compliance issues.
- Provide guidance to manufacturing site teams through virtual meetings, calls, and written communication.
- In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
- Expertise in validation methodologies and regulatory guidelines.
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
- Ability to manage cross-functional teams and prioritize tasks.
- Proficiency in QMS tools and software.
- A bachelor's degree in a life science or related field.
- Minimum 5 years of experience in quality assurance or a related field.
- Proven track record of successfully managing multiple projects and priorities.
