Senior Executive/ Manager

sun pharma industries

10 - 15 years

25 - 35 Lacs

vadodara

Posted:2 days ago| Platform:

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Skills Required

cqa excel edms senior executive pharma corporate inspection continuous improvement quality compliance inventory

Work Mode

Work from Office

Job Type

Full Time

Job Description

Maintain a comprehensive database of regulatory inspections conducted across Sun Pharma sites.
Assess regulatory inspection citations from internal sites to identify and implement global corrective and preventive actions.
Evaluate internal learnings such as Quality Alerts and consultant observations to derive global actions.
Analyse FDA enforcement actions (e. g. , Form 483s, Warning Letters issued to other organizations) to proactively identify risks and define global actions.
Develop and implement global actions, including:

Reviewing relevant regulatory guidance
Assessing current site practices
Drafting global action recommendations
Preparing reference procedures and formats for implementation
Finalizing recommendations in consultation with the Global Action Committee and stakeholders
Issuing and approving global actions in TrackWise

Coordinate with manufacturing sites to ensure effective implementation of global action recommendations.
Review site-level action closures for completeness and accuracy.
Ensure closure of global actions once all associated site action records are completed.
Communicate global action status to relevant stakeholders regularly.
Share internal and external learnings across the organization to promote continuous improvement.
Review draft responses to regulatory inspection observations for quality and compliance, as needed.
Maintain and analyse inspection observation trends across sites to identify improvement opportunities.
Perform additional duties as assigned by the Head of Corporate Quality Compliance and CQA.
Hands on experience in Trackwise, EDMS and Microsoft Excel, Pivot, etc.

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