Detail:Broad Purpose / Function :
Position Purpose :
Responsible for the analysis of samples entering the laboratory
Range :
Internal: Manufacturing, R&D, and Stability
External: Suppliers of Laboratory chemicals, detergents, reference standards
Duties / Responsibilities :
MAINTAINING OPERATIONS OF THE QUALITY CONTROL (QC) LABORATORY
Ensures that consumables are in stock Maintain general flow of through laboratory No out-of-stock consumables in laboratory Follow system put in place SAMPLING AND TESTING Samples and tests all items that require analytical assessment including but not limited to raw materials, intermediate production and finished goods as part of Lot Release where applicable. Monitors quality of the Reverse Osmosis (RO) water in the laboratory. Production Lot Release completed on due dates. Reports on findings from analytical testing. TEST METHODS Performs various test API Assay and Identification Test physical requirements of raw materials and finished goods Checking product packaging Stability testing Test are completed on scheduled due dates. Maintain Goods Receiving logbooks. API (Active Pharmaceutical Ingredient) ENVIRONMENTAL CONTROL Performs various monitoring, such as but not limited to: Environmental Health and Safety (EHS) controls Temperature monitoring and control Maintain GLP Maintain logbooks No deviations. Maintaining logbooks according to your assigned responsibilities. Report findings to superior or relevant department. GLP – Good Laboratory Practices LABORATORY COMPLIANCE WITH REGULATORY AND CORPORATE REQUIREMENTS Compliance with relevant GLP requirements. SOP’s for instruments compiled and update. Ensure trained on latest SOP relevant to your responsibilities and general laboratory quality standards. Instruments calibrated per procedure. Maintains housekeeping standards in the laboratory. No areas of Special Concern identified as a result of internal or external audit findings only latest SOP’s as per QSI index. Instruments calibrated on schedule. No visible chemical spills, broken glassware, microbiological contamination, untidy bench, damage to instrumentation or support devises, etc, TEST RESULT investigations Investigation of OUT Of Trend (OOT) and Out Of Specification (OOS) results in accordance with specified SOP’s and methods specifications. Completed within specified time frame. Root cause established following investigation. ENVIRONMENT, HEALTH & SAFETY Understand and implement relevant EHS Guidelines and performance expectations. Ensure that colleagues understand their roles and responsibilities and maintain compliance to relevant EHS guidelines and legislative requirements in accordance with participate in EHS. Reviews related to facility operations. No major EHS, ISO, J&J audit findings. Lab incidents rates. Training records. Methods developed to not use hazardous or environmentally harmful reagents. Continuous Improvement programme.
