Senior Role - Quality Control - Active Pharmaceutical Ingredients

API Quality Control - Dabhasa

- This position is responsible for overall Quality Control 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 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 deliverables.

- Trouble shooting of instrument related issues and timely resolution by coordinating with the service engineer.

- Perform periodic gap analysis and ensure implementation of identified improvements in Laboratory compliance.

- Review of specifications, STP, TDS, protocols, Analyst

- Qualification and analytical method validations 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 quality control 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 department personnel is carried out and adopted according to the need.

- Training of department personnel on the principles of good laboratory practices and good manufacturing practices

- Facing Regulatory and customer audits of the sites.