Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Piramal Pharma Solutions (PPS)
Designation : Senior Research Associate-AD
Function : Research & Development
Functional Area : Analytical Development
Job Role Summary : Review of QMS events, Method Validation, Qualitfication documents, Clinical Batch release and stability data, ensure compliance
Job Profile :
  • Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement.
  • Ensure review of daily verification/calibration of pH meter, balances and TOC.
  • Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner.
  • Thorough review of method development report and investigation study report
  • Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view.
  • Randomly review of standard, column and chemical management logbooks.
  • Ensure in-house compliance system.
  • Randomly review of QMS activities (i.e. change control, incident, deviation).
  • Thorough review of IQ/OQ and PQ of instrument/equipment.
  • Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP.
  • Perform internal audit of AD and provide appropriate training to AD team.
  • Tracking and monitoring of calibration planner and preventive maintenance planner.
  • Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level.
Job Requirements :

Experience in Analytical Development, Analytical Validation, Laboratory compliance.

Type of Experience : Pharma Analytical Development, Validation Quality control
Academic Qualifications :

M. Pharm/ M.Sc. Chemistry

Website Linkedin Piramal Pharma Solutions (PPS)

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