Manager - Quality Control - Formulation

Looking for QC Manager Profile with one of leading company having good knowledge in formulation for Nasik location.

The main criteria will be:

1. Should be able to grasp and share QC issues for escalation - both Technical and Resource related. Be open to discussions and deliberations in the meetings.

2. Should closely monitor routine QC and Analytical R& D activities related to testing, New Method Development, Validation, Transfer and Stability Studies.

3. Should be flexible and capable of continuous Resource reconciliation (planning, work allocation and co-ordination)factoring in resource availability and urgency.

4. Should have complete understanding of Data Integrity in concept, implementation and routine monitoring.

5. Should initiate and close OOS, Incidents, Change control, Deviation and Risk assessments per approved QA procedures.

6. Should have faced regulatory audits & accreditation like US FDA, MHRA, TGA, WHO Geneva, NABL etc.

7. Audit QC function at defined frequencies and implement CAPAs.

8. Should have hands-on experience in Testing/ Analysis, Method development and validation in Chromatography

9. Should be able to manage and deliver troubleshooting of Technical issues particularly related to Spectroscopy and Chromatography, both HPC and GC. Knowledge of ICP-MS, AAS would be an added advantage.

10. Have hands on experience in SOP implementation, Qualification, Calibration of Analytical instruments with 21 CFR Part 11 compliance.

11. Have hands on experience in Training laboratory personnel on Technical Aspects.

Last but not the least, he/ she be a good leader, fair team player, motivator, identify and nurture talent and leadership in the team.