Lead CAPA Effectiveness

SUN PHARMA; Vadodara; On-site; INR 3,500,000 - 6,500,000; Full time

Job summary

Sun Pharma is seeking a Lead CAPA Effectiveness at Vadodara to lead CAPA remediation and ensure regulatory compliance across sites. The role demands 15+ years in pharma quality, CAPA management, and audits, with strong cross-functional leadership and communication skills.

The incumbent will oversee CAPA implementation and effectiveness checks, support site inspection readiness, verify global action deployment, and develop plans for sustainable quality compliance across SUN sites.

Qualifications

• Minimum 15 years of experience in pharmaceutical quality and CAPA
• Proven experience in handling regulatory audits/inspections
• Experience in sterile and non-sterile pharmaceutical operations
• Strong communication and cross-functional collaboration

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.

Skills

Regulatory audits/inspections

Quality Assurance

Cross-functional leadership

Communication

Stakeholder management

Education

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

Job description

Job Description:

Job Title: Lead CAPA Effectiveness

Business Unit: Global Quality & Compliance

Job Grade: DGM

Location: Vadodara

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:

1. Responsible for Corporate Quality - CAPA effectiveness and remediation activity as per current regulatory expectations.
2. 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.
3. To support the Site inspection readiness and enhance the compliance of the site at stipulated time for anytime audit readiness.
4. To verify implementation and effectiveness of Global Action implementation at Sun Sites.
5. Develop comprehensive plan for assessment and execution for achieving Sustainable Quality Compliance across SUN sites.

Travel Estimate

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

1. Proven experience in handling regulatory audits/inspections
2. Demonstrated ability to manage cross-functional teams and stakeholder
3. Strong background in Quality Assurance
4. Mandatory experience in sterile and non-sterile pharmaceutical operations
5. 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).