10 - 15 years
8 - 17 Lacs
Posted:4 days ago|
Platform:
Work from Office
Full Time
1. Establish, implement & maintain Quality Management System as per current GxP activities including ISO/ IEC 17025: 2017.
2. Make independent and timely GxP decisions concerning quality and compliance requirements
3. Host and support regulatory and customer audits.
4. Train and coach staffs on GxP regulations. Manage GxP and ISO documentation system along with training program.
5. Establish and align Quality Assurance SOPs to guidelines and current practices.
6. To ensure that laboratory participates in various Proficiency Testing or inter laboratory comparisons conducted time to time.
7. Assess quality and compliance risks proactively to prevent recurring issues or potential risks to the Lab operations.
8. Plan an annual internal audit program, perform internal audits and follow-up on corrective actions.
9. Handle deviations, Out-of-Specification (OOS) investigations, customer complaints, and Corrective and Preventive Actions (CAPA) in a timely manner.
10. Manage the change control system.
11. Identify of deviations from the management system or from the procedures for performing laboratory activities and initiate actions to prevent or minimize such deviations.
12. Report to laboratory management on the performance of the management system and any need for improvement
13. Ensuring the effectiveness of laboratory activities.
14. Assist in the review of Quality Agreements with customers.
15. Coordinate the Management Review Meetings with Management and escalate quality issues to management in a timely manner.
16. Any other job assigned time to time by the Management.
Cotecna Life Sciences India Private Limited
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