Job Description

JOB DESCRIPTION
Job Title: ITQA Lead
Level : Expert
Job Location: Syngene International Limited, Bengaluru
About Syngene: Syngene ( ) Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world. Syngene's clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240-strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.
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

Core Purpose of the Role:
The ITQA Lead is responsible for establishing and maintaining quality assurance processes for IT systems, ensuring compliance with regulatory standards, and driving continuous improvement in IT quality practices. This role involves managing validation activities, risk assessments, audits, and collaborating with cross-functional teams to ensure IT systems meet business and compliance requirements.
Role Accountabilities:

• Review and approve validation deliverables including Impact Assessments, User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Reports compliant with 21 CFR Part 11, EU Annex 11, and GAMP5
• Implementation of ERP systems (Ex SAP, EDMS, Track Wise....) and maintain the system in validated state.
• Plan and execute installation, operational, and performance qualification (IQ, OQ, PQ) testing to verify system functionality and compliance
• Identify compliance risks proactively and implement corrective/preventive actions
• Mentor and guide junior team members on validation compliance best practices
• Manage investigation and closure of deviations and issues arising from validation and audit activities
• Develop and implement ITQA policies, procedures, and governance frameworks.
• Oversee Computer System Validation (CSV) for GxP and non-GxP systems.
• Ensure compliance with regulatory requirements (e.g., FDA, EMA, ISO, GDPR).
• Conduct risk assessments and manage remediation plans for IT systems.
• Lead internal and external IT audits and vendor assessments.
• Define and monitor QA metrics and KPIs for IT systems.
• Provide training and guidance on ITQA processes to stakeholders.
• Collaborate with IT, QA, and business teams to ensure quality objectives are met.
• Drive continuous improvement initiatives in IT quality processes.
• Mentor and guide junior team members on validation compliance best practices
• Manage investigations and closure of deviations and issues arising from validation and audit activities.

Syngene Values
All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role
Required Qualifications

• Master's degree in Science, Pharmacy, Biotechnology, B. Tech, or IT-related field.
• Strong knowledge of regulatory compliance (GxP, GDPR, ISO standards).
• Hands-on experience with Computer System Validation (CSV) and risk-based approaches.
• Familiarity with IT infrastructure, cloud systems, and cybersecurity principles.
• Excellent understanding of audit processes and vendor management.

Key Skills

• Technical Skills: IT systems validation, QA frameworks, risk management, audit readiness.
• Soft Skills: Leadership, stakeholder management, communication, problem-solving.
• Tools & Technologies: Knowledge of QA tools, documentation systems, and IT compliance platforms.

Preferred Qualifications

• Experience in pharmaceutical, biotech, or regulated industries.
• Certifications such as CISA, ITIL, or GAMP 5.
• Exposure to automation tools for QA and compliance.

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.

Skills Required