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

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.

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!

Disclaimer : The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Skills Required

Trackwise EDMS, Microsoft Excel Pivot