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.