
Senior In-Process Quality Assurance Professional
13 hours ago
Quality Assurance Specialist
This position is responsible for ensuring the quality of in-process products and facilitating collaboration among cross-functional teams.
Key Responsibilities- Review and approve batch records and packaging records to ensure completeness, accuracy, and compliance with regulatory requirements.
- Coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
- Analyze electronic data for trends or recurring issues and prepare summaries for cross-functional teams.
- Review and assess 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.
- 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 etc.).
- Strong analytical and problem-solving skills.
- Effective communication and documentation skills.
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