Key Responsibilities:
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.
Collaborate with R&D and QC teams to drive continuous improvement and compliance risk mitigation in laboratory operations.
Required Experience, Knowledge & Skills:
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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