Manager - Computer System Validation (CSV)

Syngene International Limited; Bengaluru; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

Syngene International Limited in Bangalore invites an experienced professional to lead Computer System Validation activities in a regulated environment. You will own CSV lifecycle deliverables and ensure compliance with global standards.

The role requires 6–13 years of experience, a Master’s in Science, and hands-on experience with US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. You will coordinate audits, manage risk assessments, and maintain validation documentation.

Qualifications

• 6–13 years of experience in CSV/Computer System Validation in regulated environments.
• Master’s in Science (M.Sc.).
• Experience with US FDA 21 CFR Part 11, EU Annex 11, and GAMP 5; knowledge of data integrity.

Responsibilities

• Support validation activities for GxP computerized systems and applications.
• Prepare and maintain CSV documentation (VP, URS, FS, IQ/OQ/PQ, VSR).
• Execute validation testing and document results.
• Assist in audits and inspections and remediation.

Skills

CSV

Documentation

Quality systems

GxP compliance

Education

Master’s in Science (M.Sc.)

Job description

Date: 28 Aug 2026

Location: Bangalore, KA, IN, 560100

Division: Discovery Services

Job Description

Job Title: Manager – CSV

Job Location: Translational Health Science and Technology Institute (TSHTI) - Faridabad, Haryana

Department: Human Pharmacology Unit - Translational & Clinical Research

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Role Accountabilities

Computer System Validation

• Support validation activities for GxP computerized systems and applications.
• Prepare, review, and maintain CSV lifecycle documentation including:
• Validation Plans (VP)
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Risk Assessments
• Traceability Matrix (TM)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Validation Summary Reports (VSR)
• Execute and document validation testing activities.

Regulatory Compliance & Quality

• Ensure compliance with:
• US FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5 Guidelines
• Data Integrity requirements
• GxP regulations (GCP, GLP, GMP)
• Support Electronic Records and Electronic Signatures (ERES) assessments and remediation activities.
• Participate in Data Integrity assessments and compliance initiatives.
• Assist in maintaining systems in a validated state through change management activities.

Quality Management System (QMS)

• Support investigation, documentation, and closure of:
• Deviations
• CAPAs
• Change Controls
• Audit Observations
• Participate in periodic review activities for computerized systems.
• Ensure validation deliverables comply with internal procedures and quality standards.

Audit & Inspection Support

• Support internal, customer, and regulatory audits.
• Assist in preparation and presentation of CSV documentation during audits and inspections.
• Support remediation activities related to audit findings.

Syngene Values

• Excellence
• Integrity
• Professionalism

Experience: 6 to 13 Years

Education: Master’s in Science (M.Sc.)

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.