Job Title:Proposals Engineer

Detail:Broad Purpose / Function:Position Purpose:Responsible for the analysis of samples entering the laboratoryRange:Internal: Manufacturing, R&D, and StabilityExternal: Suppliers of Laboratory chemicals, detergents, reference standardsDuties / Responsibilities:MAINTAINING OPERATIONS OF THE QUALITY CONTROL (QC) LABORATORYEnsures that consumables are in stockMaintain general flow of through laboratoryNo out-of-stock consumables in laboratoryFollow system put in placeSAMPLING AND TESTINGSamples 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 METHODSPerforms various testAPI Assay and IdentificationTest physical requirements of raw materials and finished goodsChecking product packagingStability testingTest are completed on scheduled due dates. Maintain Goods Receiving logbooks. API (Active Pharmaceutical Ingredient) ENVIRONMENTAL CONTROLPerforms various monitoring, such as but not limited to:Environmental Health and Safety (EHS) controlsTemperature monitoring and controlMaintain GLPMaintain logbooksNo deviations. Maintaining logbooks according to your assigned responsibilities. Report findings to superior or relevant department. GLP - Good Laboratory PracticesLABORATORY COMPLIANCE WITH REGULATORY AND CORPORATE REQUIREMENTSCompliance 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 investigationsInvestigation 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 & SAFETYUnderstand 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.