Responsible for overall Quality activities, which include Review and approval of SOPs & Guidelines in cross-functional teams and monitoring their effective and practical implementation in view of Good laboratory practicesReview and approval of Specification & Test methods, Certificate of Analysis of new product-related raw materials, intermediates, in-process and cleaning. Qualification of reference standards.Personnel training to follow the procedure as mentioned in the document and to prepare a functional training plan.Issuance of registers, LNB and formats for all departments involved in the development of new products in the R&D Center.

Prepare/Review of Process development report Handling of Change control, Deviation & OOS for its completion and closer with proper justification & supporting documents.Data Review (Protocols, Instrument calibration and usage Records).Calibration of analytical instruments and their documentation.Active participation in Quality Risk Assessment and Product and System Development.

Development, commercialization, documentation of developed products.Evaluation of patents for non-infringement and drafting of patents.Design , development and technology transfer of products as per the requirement.Development of multi-step products.Conducting validation and stability studies.