Quality Assurance Professional
23 hours ago
The role of a Quality Assurance Specialist is crucial in ensuring that products meet the required standards and regulations. This involves conducting thorough reviews, audits, and inspections to guarantee compliance.
Key Responsibilities- Review and approve batch manufacturing records, batch packaging records, and other relevant documents for accuracy and completeness.
- Coordinate with cross-functional teams to resolve discrepancies and missing documentation.
- Conduct electronic in-process control data review, critical process parameter logs, and environmental monitoring results analysis.
- Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
- Analyze electronic data for Annual Product Quality Review reports, identify trends or recurring issues, and prepare remote review summaries.
- 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.
- 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.
Requirements:
- 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.
Education:
- Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
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