**Job Description Summary** Validation and Batch release **Job Description** Review and approval of Process validation Protocol and Report. Review and approval of Scale Up plan, Engineering Batch Protocol and Report. Review and approval of Exhibit Batch Protocol and Report. Review and approval of Packing validation Protocol and Report. Review of Master and Executed Batch Record (Validation, Scale-up, Exhibit, Engineering). Handling of New Product Introduction activity. Review and approval of protocol and Report as part of Investigation. Review and approval of Hold time study protocol and Report. Review and approval of Cleaning validation and verification protocol and Report. SOP preparation, review, and approval. Participation in Walkthrough & Self Inspection activity. Preparation of Impact assessment & Risk assessment Documents. Participation in Incident investigation, OOT & Out of Specification Investigation (phase II) activities. Change control review and approval, monitoring of activities related to Process Validation. To follow the procedures pertaining to the environmental management system Support in implementation new procedure related to environment management system. Report any observation / non-conformance related to the environment management system. Support in implementation and maintenance of 5S concept. Issuance of Documents To carry out In process Quality Assurance activity in Block-II area Preparation, Review and Approval of Annual Product Review(APR) Any Other activity assigned by QA Head. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.