Job Description :

- 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.

Company Description

- Spectrum Talent Management is a forerunner in designing Human Resources solutions specific...

Additional Information

Job type : Full time

Position type : Permanent

Vacancies : 1

Minimum experience : More than ten years

Education : Compulsory Education

Salary range:- 22,00,000 - 35,00,000 / Yearly (Gross Pay)

Category:Jobs in Quality / Testing / Process Control

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