- 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 PPL.
- Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule.
- Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS.
- Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers
- Responsible for allotting the work to the chemist within the section.
- Responsible for performing the calibrations of all instruments in section as per the schedule.
- Responsible for maintaining all the documentation online.
- Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required.
- Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis.
- Responsible for keeping instruments neat and clean and overall housekeeping in the section.
- Responsible for review of analytical data, calibration data, qualification data
- Responsible for keeping all instruments within the calibrated status.
- Responsible to do the analysis, review and release on time to support the production
- Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues.
- Responsible for real time data monitoring.
- Responsible for reviewing the analytical data received from external laboratory.
- Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates.
- Responsible for maintaining the consumption records and traceability of working/reference standards.
- Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations
- Responsible for review of SOP’s , test procedures and specifications
- Responsible for providing the training on GLP/GMP to the employees working the section.
- Responsible for releasing the batches timely manner to achieve the site requirement.
- Responsible for preparing the COA’s as per the customer requirement
- Responsible for approving/rejecting the batches in SAP
- Responsible for Controlling the cost and operate within the approved budget.
- Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments.
- Responsible for carrying out the analytical method transfers.
- Responsible for keeping the critical spare parts of the instruments.
- Responsible for Safe working conditions and clean environmental practices.
- Responsible for usages of required safety appliances in the section.
- Responsible for SFTI.
- Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches
- Responsible for training the contract persons and helpers on glassware cleaning.
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