Senior Manager - Corporate Quality Audit

Sun Pharmaceutical Industries Ltd; Mumbai; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd seeks a Senior Manager to lead internal corporate quality audits across Sun manufacturing sites from its Sun House in Mumbai. You will review laboratory controls for USP/EP/IP compliance, manage investigations, and drive CAPA closures to uphold global quality standards.

The role requires Master of Science and 18+ years of experience in pharma QA/audits with exposure to USFDA/MHRA inspections and data integrity practices.

Qualifications

• Master of Science is required.
• Minimum 18 years of experience.
• Experience in internal corporate quality audits across manufacturing sites.
• Knowledge of USP, EP, IP regulatory expectations.

Responsibilities

• Plan, conduct, and lead internal corporate quality audits across Sun manufacturing sites.
• Audit analytical laboratories, stability and microbiology including R&D Labs. (QC SME)
• Review laboratory controls compliance with USP, EP, IP, and other regulatory expectations.
• Assess laboratory investigations including OOS, OOT, atypical results, and invalidation practices.
• Evaluate data integrity controls within laboratory systems.
• Review method validation, transfer, verification, and lifecycle management processes.
• Conduct follow-up audits to verify CAPA effectiveness
• Evaluate computerized systems used in QC laboratories.
• Review inspection observations and assess compliance risks.
• Support sites during USFDA, MHRA, Health Canada, TGA, ANVISA and other inspections.
• Prepare comprehensive audit reports and assess CAPA provided for correctness and completeness
• Evaluate audit trail reviews and electronic records management
• Track audit observations and CAPA closure timelines.
• Develop corporate quality metrics and compliance dashboards.

Skills

Quality audits

Regulatory compliance

Data integrity

Education

Master of Science

Job description

Job Title:

Senior Manager

Business Unit:

Sun Global Operations

Job Grade

G9

Location :

Sun House

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:

• Plan, conduct, and lead internal corporate quality audits across Sun manufacturing sites.
• Audit analytical laboratories, stability and microbiology including R&D Labs. (QC SME)
• Review laboratory controls compliance with USP, EP, IP, and other regulatory expectations.
• Assess laboratory investigations including OOS, OOT, atypical results, and invalidation practices.
• Evaluate data integrity controls within laboratory systems.
• Review method validation, transfer, verification, and lifecycle management processes.
• Conduct follow-up audits to verify CAPA effectiveness
• Evaluate computerized systems used in QC laboratories.
• Review inspection observations and assess compliance risks.
• Support sites during USFDA, MHRA, Health Canada, TGA, ANVISA and other inspections.
• Prepare comprehensive audit reports and assess CAPA provided for correctness and completeness
• Evaluate audit trail reviews and electronic records management
• Track audit observations and CAPA closure timelines.
• Develop corporate quality metrics and compliance dashboards.

Travel Estimate

Need base

Job Requirements

Educational Qualification

Master of Science

Experience

Tenure : Min 18 Years

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).