1. Fully responsible for Stable supply of high quality of Drug Substance.2. Responsible for launching new products ( NCEs & Generics) in commercial scale3. Develop short term and long term objectives for site in line with Corporate Goal.4. Conceptualization and Implementation of new grass route projects to increase revenue of the company based on Financial projections.5. To discuss and resolve operational and yield related issues which are affecting the management … Show more 1. Fully responsible for Stable supply of high quality of Drug Substance.2. Responsible for launching new products ( NCEs & Generics) in commercial scale3. Develop short term and long term objectives for site in line with Corporate Goal.4. Conceptualization and Implementation of new grass route projects to increase revenue of the company based on Financial projections.5. To discuss and resolve operational and yield related issues which are affecting the management objectives.6. Exploring and implementation of new technologies to reduce operating cost of the company8. Proposing and managing the site budgets both OPEX and CAPEX. 9. Ensure the appropriate systems are in place in terms of compliance with all statuary licenses. 10. Ensure that the required system and regular review are in place to provide customers with the best possible service with regards to product delivery or any other technical support. 11. Ensure that optimal resource allocation in all departments and ensure that targets are consistently achieved.12. Implementing cost saving projects in terms of process, energy and water etc 13. Focusing on creating a safe working environment for employees and visitors.14. Set priorities and fixing accountabilities15. Ensure that the employee motivation and morale are kept high at all times.Achievements:1. Successfully Cleared two FDA without any Observation.2. 15 products validated and 12 US DMFs filled & 8 products are commercialized. 3. Commissioned State of the art fully automated API facility with fully automated facility to handle two APIs at any given point of time. Project cost is 65 Crores.4. Initiated few energy saving & water saving programme to reduce operation cost5. Successfully implemented Electronic Documentation system QUMAS, SAP, Master control, Track wise, Work day and success factor. Show less

Job profile: 1. Co-coordinating the implementation of Quality systems in accordance to GxP and monitor the Regulatory Compliance of Actavis, API division, India.2. Monitor the key quality performance indicators and report the status to the management3. Managing Regulatory Affairs and Compliance functions of API division of Actavis, India4. Plan and Perform audit of supplier and Contract Manufacturers.5. Technical support to customers and Release the products… Show more Job profile: 1. Co-coordinating the implementation of Quality systems in accordance to GxP and monitor the Regulatory Compliance of Actavis, API division, India.2. Monitor the key quality performance indicators and report the status to the management3. Managing Regulatory Affairs and Compliance functions of API division of Actavis, India4. Plan and Perform audit of supplier and Contract Manufacturers.5. Technical support to customers and Release the products manufactured at the site 6. Liaison with regulatory Agencies EU & US and customers for all quality and regulatory related matters. 7. Ensure timely submission of DMFs, its amendments/variations, updates/annual reports and response to DMF deficiencies to various regulatory authorities.8. Provide quality and regulatory guidance to API cross-functional teams.9. Supervise the complete GMP training and internal Audit Program Achievements 1. Instrumental in setting the Quality Systems in line with Corporate and Regulatory guidelines and successful completion of 3 FDA and EMA inspection without any issues.2. Developed a very strong and highly motivated team for the Q functions3. Filling of DMFs & Timely notification to the management on Compliance issues Show less

Heading Quality Assurance & Regulatory Affairs function of API.1. Successfully Cleared two FDA inspections and EMA inspection.2. Ensured stable supply with high quality to Customers.3. 15 products validated and 12 US DMFs filled & 8 products are commercialized. 4. Successfully implemented Electronic Documentation system QUMAS, JDE.5. Regulatory & Technical support to customers. 6. Provide quality and regulatory guidance to API cross-functional teams. 7. Monitoring… Show more Heading Quality Assurance & Regulatory Affairs function of API.1. Successfully Cleared two FDA inspections and EMA inspection.2. Ensured stable supply with high quality to Customers.3. 15 products validated and 12 US DMFs filled & 8 products are commercialized. 4. Successfully implemented Electronic Documentation system QUMAS, JDE.5. Regulatory & Technical support to customers. 6. Provide quality and regulatory guidance to API cross-functional teams. 7. Monitoring Stability Studies and approving of stability report.8. Escalate non-compliance to Management. Show less

1. Heading over all Site Quality Assurance functions and report to General Manager QA. 2. Release the products manufactured at the site 3. Provide timely support to Regulatory Affairs by verifying the compliance to the commitments provided in the various regulatory submissions. 4. Lead and Participate in Audits conducted by different regulatory agencies WHO-GMP audit by Drug Control Boards, ISO Quality system audits and Customer audits, etc.,5. Ensuring root cause… Show more 1. Heading over all Site Quality Assurance functions and report to General Manager QA. 2. Release the products manufactured at the site 3. Provide timely support to Regulatory Affairs by verifying the compliance to the commitments provided in the various regulatory submissions. 4. Lead and Participate in Audits conducted by different regulatory agencies WHO-GMP audit by Drug Control Boards, ISO Quality system audits and Customer audits, etc.,5. Ensuring root cause analysis for failure and investigation6. Approval of Qualification (DQ, IQ, OQ and PQ) and Validation (VMP, VPP, Process, Drying, Blending and Cleaning validations and other Quality system documents.7. Evaluation of all GMP incidents to determine if they impact. 8. Regulatory & Technical support to customers. 9. Provide quality and regulatory guidance to API cross-functional teams. 10. Monitoring Stability Studies and approving of stability report.11. Escalate non-compliance to Management.Achievements 1. Implemented quality systems in the organization as per ICH Q7 and Instrumental in ISO 9002 certification. 2. Instrumental in obtaining Certificate of Suitability (COS) from EP for two APIs. 3. Supported Successful German Authority audit inspection 4. Successful audit and approval from five major customers for exclusive supply. Show less

Responsible for Corporate Quality Assurance functions.