Executive Quality Control Pharmaceuticals

**JOB TITLE** **Executive/Sr. Executive, Quality Control, Pharmaceuticals** **Specific additions-** **Responsible for LCMS section of Quality control** **_JOB PURPOSE_** **Generic** Implement quality control activities for Pharmaceuticals at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics. **REQUIREMENTS** **Education / Experience** Post Graduate in Science (Organic or Analytical Chemistry ) 2-5 years in a Pharmaceutical Company. **Technical skills &** **Competencies / Language** * Analytical ability * Trouble shootings * Co ordination * Communication **KEY ACCOUNTABILITIES** **Technical expertise:** Operation and calibration of LCMS/MS instrument for the testing of Nitrosamine, NDSRI as per current regulatory guideline. Performing Analytical method validation/verification/transfer for Nitrosamine, NDSRI and GTX impurities on LCMS/MS. Troubleshooting of LCMS instruments during routine use. **Testing** Performing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals. Performing analysis of market complaints, Stability, process validation samples, Cleaning Validation of Pharmaceuticals. Testing on nitrosamine and related impurities. **Good Laboratory Practice** Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Reviewing pharmacopeia's for specification preparation. Preparing SOPs and Formats and Analytical Test Record. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data related to testing activity. **Validation** Preparing protocol for Analytical Method validation/verification & transfer, cleaning validation and performing the validation exercise as per the protocol for the material and drug products. Performing analytical method validation/verification & transfer for nitrosamine and NDSRIs using LCMS/MS Analytical method development and related troubleshooting samples on LCMS/MS. **Management of laboratory Consumables** Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material. **Co ordination** Coordinating with production, and warehouse for analytical activities. **Other** Compliance to HSE Requirements for QC Laboratory Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.