Lupin Career | QC Manager Job in Gujarat

Manager – GLP (QC) – Lupin 


Location: Dabhasa, Gujarat

Company: Lupin Limited

  • Responsible for Analyst Qualification, Calibration, Qualification of Instrument/Equipments, SOP, Column Management, Procurement and Capex, Preventive Maintenance, Computer system Validation, Audit compliance  and Working standard activity.
  • Ensure planning and execution of all activity in GLP section.
  • Responsible for review of SOPs, GTPs, specification, Protocol for stability, Protocol of Analytical Method Validation/Transferred/verification and other non-routine activity.
  • Responsible for Approved of Calibration of Instrument/Equipments.
  • Responsible for Usage Decision for Calibration of Instrument/Equipments through SAP and review of preventive Maintenance through SAP.
  • Responsible for Investigation of non-conformities like deviations, out of specifications, out of trend, failures, Market complains etc. and derive appropriate Corrective and preventive actions.
  • Responsible for execution and review of software validation documents.
  • Laboratory maintenance as per QC GMP compliance and usage of PPE’s at shop floor by self, co-employees and contractual workmen.
  • Issuance of calibration data sheet and test data sheet for RM, PM, FP, INT and stability.
  • Responsible for Preventive Maintenance and AMC of Equipment and instrument.
  • Review of Temperature and Humidity record, Daily Monitoring Record, External Calibration Record, IQ, OQ, PQ record of instrument/Equipment.
  • Responsible for provide training on revised SOP, New SOP and CAPA.
  • Responsible for review of change control, deviation, CAPA, incident, Reprocess in QAMS.
  • Responsible for review of Effective Monitoring of CAPA.
  • Coordinate with RA for filling the requirements of various regulatory submissions.
  • Responsible for preparation of AMC/CMC PO.
  • Responsible for initiation of capex items.
  • Laboratory maintenance as per GLP complies.
  • Training of staff, To ensure 100% TNI throughout the year.
  • To perform internal audits as per schedule.

 

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