Teva Sr Mgr MS & 

India, Uttar Pradesh 

148790267

• Responsible to review the change control for site initiation for New Product/ Stage/ Campaign. Accordingly arranging the other documents to execute batch in the plant like Tech pack, Risk assessment, PSSR, PID etc.
• Responsible for coordinating with other departments like Warehouse, Engineering, QC, Process Engineering, PR&D, HSE & QA to complete start up activities as per the time line.
• Review process with respect to Quality, Safety, Yield, and Waste management, availability of Utility source and accessories. Collecting relevant details from PE & PR&D to execute the batch smoothly.
• During initiation of New product/ stage or change in process, training shall be imparted to concern subordinates and Production team.
• Responsible to track the batch status w.r.t Quality, Yield, Cycle time according to dispatch time line by co-ordination with Production team.
• Verifying data with respect to critical parameters, purity and yield along with batch cycle time of previous batches before executing new campaign / batches.
• Responsible to report the deviations/ observations /abnormalities immediately to Superiors & Concern persons.
• Guide team to achieve targets and support on technical evaluation of new, Site transfer and existing products
• Responsible to complete the investigation (Product deviation & OOS) w.r.t process
• Responsible for technical troubleshooting the problem arised during process execution.
• Responsible for ensuring safety practices & instruct to subordinates for the same.
• Responsible to ensure the RM approved stock availability in advance for batch charging to meet dispatch target.
• Responsible for assigning job and monitoring subordinate persons activities
• Regulatory Support for annual DMF updates
• Analytical method review and cross validation as required.
• Develop process for various API and its implements as a requirement.
• To review of all lab documents.
• New process scale up, proves validation and commercialization by following TAPI Technology transfer policy and meeting regulatory requirements.
• Improvement in the yield, efficiency and cost effectiveness of developed API’s by introducing new Technologies and development of process.
• Providing the impurities, Markers and standards for IH and customers.
• Evaluation and sign off CCM/Protocols received from manufacturing.
• Coordination between intra and inter sites for technical aspects.
• Responsibility for ensuring UT of raw material, intermediates, and solvents required to verify new vendor as and when required.
• Establishing the solvent recovery and reusability in Lab and issue the reports.
• Generation of safety reports as and when required.
• Trouble shooting for the plant related problems, to overcome the process related difficulties for smooth production.
• Support to answer deficiency Letters received from regulatory Authorities.
• Support to answer quarries received from customers.
• To maintain GMP in Lab.
• Coordination with other departments from smooth functioning.
• Develop own skill by way of reading / attending seminars etc.
• To maintain discipline and dignity of the organization.
• Contribute novel ideas by way of participation during technical discussion with superiors/ Colleagues

• Master of Science/ Ph.D. (Chemistry) or B.Tech/M.tech Chemical
• 12-15 Years experience & 5 years in people management
  

Associate Director, MS&T