Senior Executive/ Manager - Corporate Quality Compliance

Title:

Senior Executive/ Manager - Corporate Quality Compliance

Business Unit:

Global Quality and Compliance 

Job Grade:

G10

Location:

Vadodara

Key Responsibilities

Create your own sunshine

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 –

1. Maintain a comprehensive database of regulatory inspections conducted across Sun Pharma sites.
2. Assess regulatory inspection citations from internal sites to identify and implement global corrective and preventive actions.
3. Evaluate internal learnings such as Quality Alerts and consultant observations to derive global actions.
4. Analyse FDA enforcement actions (e.g., Form 483s, Warning Letters issued to other organizations) to proactively identify risks and define global actions.
5. 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
6. Coordinate with manufacturing sites to ensure effective implementation of global action recommendations.
7. Review site-level action closures for completeness and accuracy.
8. Ensure closure of global actions once all associated site action records are completed.
9. Communicate global action status to relevant stakeholders regularly.
10. Share internal and external learnings across the organization to promote continuous improvement.
11. Review draft responses to regulatory inspection observations for quality and compliance, as needed.
12. Maintain and analyse inspection observation trends across sites to identify improvement opportunities.
13. Perform additional duties as assigned by the Head of Corporate Quality Compliance and CQA.
14. Hands on experience in Trackwise, EDMS and Microsoft Excel, Pivot, etc.

Travel Estimate

30%

Job Requirements

Educational Qualification

M Pharm / MSC

Experience

10+ yrs

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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