Manager - Corporate Quality Audit

Sun Pharmaceutical Industries, Inc.; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd invites a Manager - Corporate Quality Audit to lead risk-based IT audits of GxP systems, ensuring data integrity and regulatory compliance.

You will assess IT general controls, review system logs, and prepare audit reports while supporting regulatory inspection readiness, collaborating with Quality, Manufacturing, and IT teams.

Master of Science or B Pharmacy or equivalent is required; Sun Pharma offers a dynamic environment with growth opportunities.

Qualifications

• Experience in planning and executing risk-based IT audits of GxP systems.
• Knowledge of regulatory guidelines (USFDA, MHRA, EMA, WHO) and data integrity concepts.
• Strong collaboration with Quality, Manufacturing and IT teams.

Responsibilities

• Plan and execute risk-based IT audits across Sun Pharma's GxP systems, infrastructure, applications and technology processes.
• Assess Data Integrity, CSV, ITGCs and regulatory expectations including USFDA, MHRA, EMA and WHO guidelines.
• Evaluate audit trails, system logs, electronic records and user activities to identify deviations and risks.
• Prepare audit observations with risk ratings and remediation recommendations; develop CAPA follow-ups.

Skills

IT audit

GxP knowledge

Regulatory compliance

Education

Master of Science / B Pharmacy or equivalent

Job description

Company: Sun Pharmaceutical Industries Ltd

Title: Manager - Corporate Quality Audit

Job Title:

Manager

Business Unit:

Job Grade

G10

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:
• Plan and execute risk-based IT audits across Sun Pharma's GxP systems, infrastructure, applications, and technology processes.
• Assess compliance with Data Integrity requirements, Computer System Validation (CSV) principles, internal policies, and applicable regulatory expectations including USFDA, MHRA, EMA, and WHO guidelines.
• Evaluate IT General Controls (ITGCs) including user access management, segregation of duties, password controls, change management, backup and recovery, business continuity and system documentation life cycle controls.
• Review enterprise systems, laboratory systems, manufacturing systems, quality systems, and cloud-based applications for compliance, security, and data integrity risks.
• Conduct thorough reviews of audit trails, system logs, electronic records, and user activities to identify process deviations.
• Assess the effectiveness of controls related to computerized systems supporting manufacturing, laboratory, warehousing, quality assurance and quality control.
• Identify control weaknesses, compliance gaps, and operational risks; develop risk-rated audit observations and practical remediation recommendations.
• Prepare audit reports, review response to the audit observations in timely manner for implementation and effectiveness of corrective and preventive actions (CAPAs), prepare executive summaries, and management presentations highlighting key risks, business impacts, and recommended actions.
• Support regulatory inspection readiness activities, as applicable.
• Collaborate with Quality, Manufacturing, Engineering and Information Technology during audit engagements.
• Monitor evolving regulatory expectations, cybersecurity threats, and industry best practices relevant to pharmaceutical computerized systems.
• Support continuous improvement of Sun Pharma's IT audit methodology, risk assessment processes, and data integrity assurance program.

Job Requirements

Educational Qualification

Master of Science / B Pharmacy or equivalent

Experience

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).