Executive Quality Control

Key Responsibilities • Initiation of QMS elements i.e. Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable. • Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable . • Preparation of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols and reports etc. • Review of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheet, calibration data sheets, protocols and reports etc. • Reviewing LIMS/ELN relevant documentation, SOP s, training presentations, and any other documents related to CSV requirement for any enhancements or new implementation/Modules. Collaborating with IT and QA to facilitate validation activities, writing/execution/review of Test Scripts, and effective implementation of LIMS. Ensuring the proper functioning of LIMS application as per the business needs through rigorous testing. • Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable. • Review of documents and records related to routine operations in quality control. Review of documents in EDMS and TrackWise. • Involving in Investigation and closure of OOS, OOT, Laboratory incidences, deviation and Non-Conformity as applicable. • Check consignment documents like COA, MSDS, GRN, TRF, FTRF etc and monitor sampling of Raw materials, Packing materials, In-process, Validation, Finished products, water sampling and miscellaneous materials as applicable and certify the accuracy, adequacy and timeliness of the activity performed by analysts. • Responsible for imparting training to New joiners, Consultants, Deputation Transfer etc. • Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.