Lupin—Executive - QA

Job description

Description: Job Description - Compliance to the instructions given in Batch records of various products. - Ensuring the compliance of the SOPs and cGMP requirements at shop floor. - Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process. - Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance. - “Sampling” at different stage of manufacturing or as per the requirement. - Stage wise review of batch records and compliances if any, to facilitate timely release. - Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification. - Review of master batch manufacturing record and batch packing record in SAP - Active participation in execution of Qualification and calibration activity. - Periodic review and preparation of APQR. - Handling of CAPA, Change controls, OOS, OOT, Laboratory Incidence, Market complaint & Deviations through QAMS. - Co-ordination & execution of Self Inspection and compilation of self-inspection observations. - Active participation in investigation related to product / system failure. - Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training. - Active Participation in Batch Release Activity. - Handling eDMS activities. - Active participations in all the IPQA activities. Work Experience 6-9 years Education Graduation in Pharmacy Competencies