Piramal - Chief Manager - Quality Control

- 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