Key Roles & Responsibilities
1. Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC.
2. Responsible for allotting the work to the chemist within the QC department.
3. Responsible for performing the calibrations of all instruments in QC as per the schedule.
4. Responsible for maintaining all the documentation online.
5. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required.
6. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis.
7. Responsible for keeping instruments neat and clean and overall housekeeping in the FP section.
8. Responsible for review of analytical data, calibration data, qualification data.
9. Responsible for keeping all instruments within the calibrated status.
10. Responsible to do the analysis, review and release on time to support the production.
11. Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues.
12. Responsible for real time data monitoring.
13. Responsible for reviewing the analytical data received from external laboratory.
14. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates.
15. Responsible for maintaining the consumption records and traceability of working/reference standards.
16. Responsible for OOS investigations, deviations and CAPA implementations
17. Responsible for review of SOP’s , test procedures and specifications
18. Responsible for providing the training on GLP/GMP to the employees working the section.
19. Responsible for releasing the batches timely manner to achieve the site requirement.
20. Responsible for preparing the COA’s as per the customer requirement
21. Responsible for approving/rejecting the batches in SAP
22. Responsible for Controlling the cost and operate within the approved budget.
23. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments.
24. Responsible for carrying out the analytical method transfers, Method validations, Method equivalency study and Method verification activities.
25. Responsible for keeping the critical spare parts of the instruments.
26. Responsible for Safe working conditions and clean environmental practices.
27. Responsible for usages of required safety appliances in the section.
28. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches.
29. Responsible to train the contract persons and helpers on glassware cleaning.
