Senior Quality Assurance Specialist
4 days ago
Our company is seeking an experienced professional to join our quality assurance team. The successful candidate will be responsible for ensuring the quality of our manufacturing processes and products.
Key Responsibilities:- 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.
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
- 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.
This role requires a strong understanding of quality management principles and practices, as well as excellent analytical and problem-solving skills. The ideal candidate will have experience working in a fast-paced environment and be able to effectively communicate with cross-functional teams.
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