DM External Auditor

Job Purpose

Handle the audit compliance reports by thorough evaluation and ensuring necessary approvals to meet regulatory compliance

Accountabilities

1. Review of external audit compliance reports of manufacturing sites and timely submission of the same to the respective authority/customer.
2. Review of CAPAs taken for audit observations to ensure those are holistic and sustainable actions.
3. Perform review of US FDA response and key regulatory authority response.
4. Ensure the compliance level of site by visiting the site prior to regulatory authority inspection.
5. To review newly released regulatory guidance, industry standards, FDA 483s, warning letters, import alerts and other regulatory non-compliances and perform gap assessments to improve Cipla s existing systems and procedures.
6. Identify potential global CAPA for implementation of best practices/ procedures to ensure harmonised systems/ practices across sites and continuous improvements.
7. Proposal of action plan based on the review of repeat non-conformance trend.

Education Qualification

M. Pharm/M. Sc

Relevant Work Experience

8-12 Years of experience

Job Location

Vikhroli