Date PostedJanuary 17, 2023
Location (State / UT)
Experience15 Years, 18 Years
Desired QualificationMaster’s Degree, Bachelor Degree
Responsible for regulatory inspection observation assessment for Inspections at SUN sites, issuance of Global actions, and initiation of Global compliance activities based on performed assessment.
Roles and Responsibilities
1. Assessment of regulatory inspection observation for identification of,
1.1 Category I citation- Requirement of Global Action
1.2 Category II & III citation- To be shared for site reference
2. Preparation of Global action based on Category I citations, the following are the sub-activities:
2.1 Review of the regulatory guidances related to the topic
2.2 Review of existing site practices
2.3 Drafting of Global action recommendations
2.4 Preparation of reference procedures and associated formats for Global action implementation
2.5 Discussion of draft Global action recommendation with relevant stakeholders
3. Issuance of Global actions in Trackwise.
4. Coordinating with sites for the implementation of Global action recommendations
5. Review of the draft response of inspection observation (As and when required)
6. Review of draft site procedures (SOPs/ protocols/ reports etc.) related to issued Global actions (As and when required)
7. Review of site action closure
8. Preparation of Inspection observation assessment report
9. Preparation and circulation of Global action status to relevant stakeholders
10. Maintaining database for regulatory inspections at SUN Pharma
11. To perform any additional activities allotted by reporting manager.
Performs all work in line with Sun Pharma’s values of Humility, Integrity, Passion, and Innovation. Performs all work in accordance with all established regulatory compliance and safety requirements.
Qualification: B.Pharma, M.Pharma, MS/M.Sc
Experience: 15-18 years