This position is responsible for overall QC function at the site. This position works closely with other organizational functions (Manufacturing, procurement, RA, R&D, PDL, ADL, PQA, CQA etc.) for ensuring timely support to Supply chain while ensuring quality & compliance.
Ensure the compliance to written procedures in routine quality control operation.
Continuous improvement in quality system to improve overall compliance in line with the GMP /GLP & regulatory expectations.
Ensure agreed service level agreement on analysis is met consistently to achieve site deliverable.
Trouble shooting of instrument related issues and timely resolution by co-ordination with the service engineer.
Perform periodic gap analysis and ensure implementing of identified improvement on laboratory compliance.
Review of specification, STP, TDS, Protocols, analyst qualification and analytical method validation documents and ensure compliance.
Investigate laboratory incidents, OOS, OOT and deviations timely and ensure appropriate CAPAs are implemented.
Ensure compliance in the aspects of calibration, preventive maintenance and any breakdown maintenance of laboratory instruments and equipment.
Review of the change controls pertaining to QC function and ensure risk assessment are performed wherever requirement in compliance to the established standard operating procedures.
Release or rejection of materials and products subject to the compliance of quality system.
To ensure that the required initial and continuing training of all dept. personnel is carried out and adopted according to the need.
Training of dept. personnel on the principles of good laboratory practices and Good manufacturing practices.
Facing Regulatory and customer audits of the sites.