Senior Manager

4 weeks 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

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