Key Responsibilities
- Establish and ensure compliance with GLP in QC laboratory operations.
- Perform routine analysis of Finished Products (FP), APIs, Raw Materials (RM), Packaging Materials (PM), and water samples.
- Supervise RM, PM, STB, and FP teams and ensure smooth QC operations.
- Manage working standards, CRS, VS, columns, reagents, glassware, and other laboratory resources.
- Oversee QC equipment handling, qualification, calibration, and documentation.
- Prepare and review SOPs, STPs, EOPs, ECPs, stability protocols, and analytical reports.
- Participate in QMS activities, including OOS, OOT, LIR, deviations, and CAPA.
- Execute stability studies and participate in validation activities, including cleaning validation, process validation (PV), HVAC, and water system qualification.
- Maintain sample retention, participate in in-house audits, and ensure proper waste disposal and laboratory safety practices.
- Coordinate with QA, Engineering, and relevant departments to support QC operations.
- Conduct safety briefings and training for existing and newly joined employees.
- Support toll manufacturing-related activities as required.
Educational Requirement
Master of Pharmacy (M.Pharm) in Pharmacy Master of Science (MSc) in Chemistry
Additional Requirements
- Advanced knowledge in MS Suite;
- Strong decision-making skill with the ability to work independently and collaboratively;
- Strong interpersonal skill to deal with internal & external stakeholders.
- Strong knowledge of GMPs guideline/GLP/GDP/ regulation/(WHO, UKMHRA,FDA, 21CFRpart 11 etc.)
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