Address- Responsible for the operations of the Quality control laboratory
- Ensure testing & release of Raw Materials, Finished products and Packaging Materials as per cGMP in time.
- Testing and release of Raw Materials, Finished products and Packaging Materials as per cGMP requirement.
- Ensure analysis of stability samples and related documentation as per cGMP requirement.
- Facing Internal audits and External Audits and ensure compliance.
- Review and approve all QC document like SOPs, STPs, GTPs etc.
- Control of operating expenses.
- Ensure effective implementation of systems and procedures as per GMP, GLP, ISO 9001, ISO 14001 and other regulatory requirements.
- Carry out OOS / OOT / incident Investigation.
- Managing of control samples.
- To review Pharmacopeia i.e.USP, BP, IP, EP and ensure that the changes proposed are implemented and relevant PHL documents are being updated before the effective date.
- Ensure Data entry and approval in system.
- Set annual performance goals for Team, monitors performance and guide them to attain it.
- On job training as necessary to develop skills and improve productivity.
- Ensure the training to new persons as per procedure.
- Review of laboratory data.
- To ensure calibration & maintenance of laboratory equipment.
- Review of work output and pending work.
- Responsible to verify and checking of audit trail functioning of all QC instruments like HPLC, GC, UV and FTIR instrument.
- Review and approve analytical method validation, verification and method transfer protocol, data and report
