Senior Executive - Quality Control

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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 - Quality Control

Job Description

Sr.Executive Quality control HPLC

• 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.
• Responsible for performing the analysis and allotting the work to the chemist within the HPLC section.
• Responsible for performing the calibrations of all instruments in HPLC section as per the schedule.
• Responsible for maintaining all the documentation online.
• 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 HPLC 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 standard’s.
• Responsible for OOS investigations, deviations and CAPA implementations
• Responsible for review of SOP’s, test procedures and specifications.
• Responsible for releasing the batches timely manner to achieve the site requirement.
• Responsible for approving/rejecting the batches in Quick flow.
• 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/Verification, and method validation.
• 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 coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches
• Responsible for training the contract persons and helpers on glassware cleaning.

Responsible for any additional activities assigned by Section In-Charge / Manager / Head Quality Control.

Master of Science (MSc)