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Senior Manager

4 months ago

Vadodara, India SUN PHARMA Full time

Job Role :


Responsibilities :

Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action

Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action

Ensure assessment of internal learning (such as Quality alert) to derive the global action

Preparation of Global action based, following are the sub-activities:

Review of the regulatory guidance related to the topic

Review of existing site practices

Drafting of Global action recommendations

Preparation of reference procedures and associated formats for Global action implementation as applicable

Finalization of Global action recommendation post review with Global action committee and relevant stakeholders

Ensure issuance and approving of Global actions in Trackwise.

Coordinating with sites for the implementation of Global action recommendations

Ensure review of site action closure for completeness and correctness

Ensure closure of global action upon completion of all issued site action records of a global action

Ensure circulation of Global action status to relevant stakeholders

Ensure compliance calls being executed as per pre-defined agenda i.e. internal and external learnings being shared and explained with stakeholders.

Ensure identified gaps being shared across sites and tracked for implementation

Ensure maintenance of database for regulatory inspections at SUN Pharma

Review of draft response of inspection observation

Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis

All other duties as assigned by Head Corporate Quality Compliance and CQA


Educational Qualification : M.SC / M. Pharm

Skills : Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile)


Experience : 15+ Yrs