Manager - Corporate Quality Audit

Sun Pharma; Mumbai; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Sun Pharma in Mumbai invites a seasoned Manager to lead risk-based IT audits across GxP systems, infrastructure, and software. You will assess Data Integrity and CSV adherence, review ITGCs, and ensure regulatory expectations (USFDA, MHRA, EMA, WHO) are met.

Collaborate with Quality, Manufacturing and IT to strengthen controls and support inspection readiness. The ideal candidate holds MSc or BPharm equivalents with at least 15 years of experience, and will drive CAPAs, audit reports and

Qualifications

• Plan and execute risk-based IT audits across GxP systems, infrastructure, applications and technology processes.
• Assess Data Integrity, CSV principles, internal policies and regulatory expectations.
• Evaluate IT General Controls including access, segregation of duties, change management, backups and disaster recovery.

Responsibilities

• Review enterprise, laboratory, manufacturing and quality systems for security and data integrity.
• Conduct audit trail, system log and electronic record reviews to identify deviations.
• Assess controls for computerized systems supporting manufacturing, QA and warehousing.
• Identify weaknesses, gaps and remediation actions; develop risk-rated observations.
• Prepare audit reports, executive summaries, and management presentations.
• Support regulatory inspection readiness; collaborate with QA, Manufacturing, Engineering and IT.
• Monitor evolving regulatory expectations and cybersecurity best practices.

Skills

IT audits

Data Integrity

Regulatory compliance

ITGCs

Collaboration

Education

Master of Science / B Pharmacy

Job description

Job Title:

Manager

Business Unit:

Sun Global Operations

Job Grade

G10

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 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.

Travel Estimate

Need base

Job Requirements

Educational Qualification

Master of Science / B Pharmacy or equivalent

Experience

Tenure: Min 15 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).