Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Dr.Reddys Laboratories
Designation : Team Member
Function : Quality Control
Functional Area : QC
Job Role Summary : Manage Analytical Instrumentation with cGMP Compliance, Maintenance, Qualification and Calibration
Job Profile :
  • Perform preventive maintenance (PM) and breakdown maintenance for analytical instruments.
  • Maintain and troubleshoot analytical equipment such as HPLC, UPLC, GC, Dissolution Testers, Karl Fischer Titrators, UV-Visible Spectrophotometers, Balances, pH Meters, and other QC laboratory instruments.
  • Prepare and execute annual preventive maintenance plans and PM checklists as per GMP requirements.
    Create purchase requisitions (PRs) for spares, consumables, and service requirements through SAP.
  • Ensure adequate inventory of critical spare parts and consumables in the warehouse to minimize equipment downtime.
  • Coordinate with OEMs and service providers for AMC, breakdown support, calibration, and spare procurement activities.
  • Conduct root cause analysis (RCA), CAPA implementation and documentation for equipment breakdowns.
  • Support audit readiness by ensuring compliance with GMP, GLP, Data Integrity, and Quality Management System requirements.
  • Participate in equipment qualification, IQ/OQ/PQ activities and new instrument installation projects.
Job Requirements :
  • Hands-on experience in maintenance and troubleshooting of analytical laboratory instruments.
  • Good knowledge of HPLC, UPLC, GC, Dissolution Systems, Titrators..
  • Working knowledge of SAP PM Module for maintenance order creation and closure.
Type of Experience : Hands-on experience in maintenance and troubleshooting of analytical laboratory instruments.
Academic Qualifications :
  • Diploma / B.Tech / B.E. in Electronics, Instrumentation, Electrical, Mechanical, or related discipline.

Website Linkedin Dr.Reddys Laboratories

To apply for this job please visit careers.drreddys.com.