Senior Executive-QC

Piramal Pharma

Marshall Islands1w ago

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Key details

Location
Marshall Islands
Work style
Onsite
Level
Senior
Job type
Full-time
Function
other
Focus area
other
Posted
1w ago

Skills

calibrationgmphplclaboratory safetyquality control

About the role

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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

Responsible for conducting quality control analysis of finished products, in-process, intermediate, miscellaneous, and stability samples as per pharmacopoeial, in-house, and customer specifications. Operate and calibrate LC-MS, HPLC, GC, analytical balances, and other QC laboratory instruments in accordance with approved procedures. Perform wet analysis of finished products, maintain accurate documentation in compliance with cGMP requirements, and ensure adherence to laboratory safety standards. Support reporting and coordination activities in the absence of the reporting authority and undertake other responsibilities as assigned by seniors.
  • Perform analysis of finished products, in-process, intermediate, miscellaneous, and stability samples as per pharmacopoeial, in-house, and customer specifications.
  • Operate and perform routine calibration of LC-MS, HPLC, GC, analytical balances, and other QC laboratory instruments as per approved SOPs and procedures.
  • Conduct wet analysis and routine chemical testing of finished product samples using approved analytical methods.
  • Ensure accurate and timely recording, review, and maintenance of analytical data, worksheets, logbooks, and other QC documentation in compliance with cGMP requirements.
  • Ensure adherence to SOPs, analytical methods, specifications, pharmacopoeial standards, and applicable quality requirements during all testing activities.
  • Identify and promptly report abnormal observations, deviations, OOS/OOT results, and other analytical discrepancies to the concerned authority.
  • Follow all applicable laboratory safety procedures, cGMP practices, and EHS requirements during analytical activities.
  • Ensure proper handling, cleaning, and upkeep of laboratory instruments and equipment to maintain reliable analytical performance.
  • Take responsibility for reporting and coordination activities in the absence of the reporting authority, as required.
  • Support the QC team in ensuring timely completion of testing, documentation, and reporting.
  • Perform other quality control-related activities and responsibilities as assigned by seniors.

 

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