Lead CAPA Effectiveness

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 6,500,000 - 10,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd is seeking a senior quality and compliance leader to drive CAPA effectiveness across Sun sites and ensure audit readiness. You will lead regulatory audits, CAPA implementation, and global action verification in a cross-functional team.

You will develop sustainable quality plans across SUN sites, mentor teams, and ensure compliance with current regulatory expectations while maintaining strong stakeholder relationships.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Chemical Engineering, or related field.
• Minimum 15 years of experience in quality and regulatory audits.
• Experience in sterile and non-sterile pharmaceutical operations.
• Strong communication and stakeholder management skills.

Responsibilities

• CAPA effectiveness and remediation per regulatory expectations.
• CAPA implementation and effectiveness checks for agency audits.
• Support site inspection readiness and audit readiness.
• Verify Global Action implementation at Sun Sites.
• Develop comprehensive plans for Sustainable Quality Compliance across SUN sites.

Skills

Regulatory audits

Cross-functional leadership

Quality Assurance

Communication

Education

Bachelor’s / Master’s Degree in Pharmacy, Chemistry, Chemical Engineering, or related field

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Business Unit:

Global Quality & Compliance

Job Grade

DGM

Location :

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.”

Key responsibilities:

• Responsible for Corporate Quality - CAPA effectiveness and remediation activity as per current regulatory expectations.
• Responsible to conduct the CAPA implementation and effectiveness check of the committed CAPA’s to regulatory agency at respective sites to assure effective corrective and preventive actions are in place as committed for compliance and ensure effectiveness verification through protocol for the committed CAPA’s to the agency as a part of Audit response.
• To support the Site inspection readiness and enhance the compliance of the site at stipulated time for anytime audit readiness.
• To verify implementation and effectiveness of Global Action implementation at Sun Sites.
• Develop comprehensive plan for assessment and execution for achieving Sustainable Quality Compliance across SUN sites.

Moderate travel (as per project, audit, or site requirements)

Job Requirements

Educational Qualification

Bachelor’s / Master’s Degree in Pharmacy, Chemistry, Chemical Engineering, or related field

Experience

Tenure : Minimum 15 years

• Proven experience in handling regulatory audits/inspections
• Demonstrated ability to manage cross-functional teams and stakeholder
• Strong background in Quality Assurance
• Mandatory experience in sterile and non-sterile pharmaceutical operations
• Good in communication

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).