• 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.