QA Senior Executive/Executive

Job Description

Quality Manual. * Preparation and Approval of Standard operating Procedures. * Preparation of Process validation Protocols and summary reports based on the Analytical results and Batch documents data. * To co-ordinate the Qualification / Validation of the Equipment, Systems and Process. * To ensure the issuance of required documents and samples for Drug and Regulatory Affairs. * To ensure the preparation, Issuance, Revision/Review and Retrieval of the documents. * To investigate the cause of any non conformance and its corrective / preventive action. * To ensure the Analytical method validation of cleaning process before conducting Cleaning validation. * Preparation of Cleaning Validation Master plan. * Preparation and Execution of Cleaning validation protocols. * Cleaning Validation Analytical Data collection and Summary report preparation cleaning validation. * To conduct or organise revalidation activity at the defined frequency. * To control the inventory of control samples. Officer/ Sr. Officer (IPQA Tab/Cap) 2-5 years Over all IPQA activity (Tab/Cap) + Validation + Licensing work (FDA) Officer/ Sr. Officer (Liquid IPQA + Validation) 2-4 years Over all IPQA activity (Liquid) + Validation