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