At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Position Summary –
- 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.