Senior Executive-QC

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Executive-QC

Job Description

ICPMS analyst

• 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.