
Senior Regulatory Compliance Specialist
15 hours ago
We are seeking a highly skilled and experienced professional to join our team as Assistant Manager - QA Laboratory Compliance.
Key Responsibilities:- Ensure strict compliance with regulatory standards and internal quality procedures in Research & Development / Quality Control section.
- Review and ensure accuracy of OOS (Out of Specification) and OOT (Out of Trend) documentation and investigations.
- Evaluate and provide QA oversight for analytical method validations, method transfers, and stability studies.
- Maintain compliance with regulatory guidelines (ICH, WHO, EU-GMP) and internal SOPs.
- Coordinate and support regulatory audits and customer inspections for laboratory systems and documentation.
- Review and approve laboratory data, including raw data, chromatograms, and electronic records for integrity and compliance.
- Support implementation and periodic review of Good Laboratory Practices (GLP) and data integrity controls in the lab.
- Monitor compliance of laboratory equipment calibration, qualification, and maintenance programs.
- Ensure timely investigation and closure of deviations, incidents, and CAPAs related to laboratory activities.
- Conduct training and awareness sessions on laboratory compliance, documentation practices, and audit readiness.
- Participate in change control assessments related to laboratory instruments, methods, and specifications.
- Assist in developing and improving SOPs, quality manuals, and lab compliance checklists.
- Master's degree in Chemistry or Applied Chemistry, or equivalent.
- 4–8 years of experience in pharmaceutical industry, preferably with experience in Quality Control, R&D Analytical Laboratory, or pharmaceutical compliance.
- Sound knowledge of GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), and ICH / WHO guidelines.
- Proficient in handling OOS/OOT investigations, CAPA, change controls, and deviation management.
- Strong understanding with analytical techniques (HPLC, GC, UV, etc.) and instrument qualification protocols.
- Well-versed in data integrity practices, ALCOA+ principles, and electronic documentation systems.
- Strong analytical, documentation review, and critical thinking skills.
- Excellent verbal and written communication skills for cross-functional collaboration.
- Self-driven, detail-oriented, and proactive in ensuring regulatory and procedural compliance.
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