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Senior Manager
1 week ago
Job Role :
Responsibilities :
Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global actionEnsure assessment of 483s, warning letter issued to other organization by USFDA to derive the global actionEnsure assessment of internal learning (such as Quality alert) to derive the global actionPreparation of Global action based, following are the sub-activities:
Review of the regulatory guidance related to the topicReview of existing site practicesDrafting of Global action recommendationsPreparation of reference procedures and associated formats for Global action implementation as applicableFinalization of Global action recommendation post review with Global action committee and relevant stakeholdersEnsure issuance and approving of Global actions in Trackwise.
Coordinating with sites for the implementation of Global action recommendationsEnsure review of site action closure for completeness and correctnessEnsure closure of global action upon completion of all issued site action records of a global actionEnsure circulation of Global action status to relevant stakeholdersEnsure 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 implementationEnsure maintenance of database for regulatory inspections at SUN PharmaReview of draft response of inspection observationEnsure Sun site regulatory inspection observations trend is in place for meaningful analysisAll other duties as assigned by Head Corporate Quality Compliance and CQA
Educational Qualification :
M
SC / M PharmSkills :
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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