
Senior Sterile Injectable Quality Assurance Specialist
7 days ago
We are seeking a seasoned Quality Assurance professional to join our team in a key role that drives quality and compliance across manufacturing operations.
This is an exciting opportunity for a detail-oriented and analytical individual with expertise in validation methodologies, regulatory guidelines, and sterile injectable manufacturing processes.
The successful candidate will play a critical role in ensuring the highest standards of quality, safety, and efficacy in our products.
- Review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) submitted from manufacturing sites 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.
- 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.
- 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.
- Maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues.
- Provide remote 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 (US FDA, cGMP etc.).
- 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.
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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