Job Description

Job Title: Digitization Lead.
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:
To act as System SME and ensure compliance activities related to ERP systems ensuring adherence to regulatory requirements and internal policies, thereby supporting quality assurance and data integrity in Syngene's operational systems.
Role Accountabilities:
Prepare, 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
Collaborate with IT, QA, and business stakeholders during system testing, deployments, and upgrades for ERP systems such as EQMS, Documentum, SAP
Assess and manage risks and impacts associated with ERP system changes and new implementations
Ensure adherence to company SOPs, regulatory guidelines, and quality standards throughout validation lifecycle
Act as subject matter expert during internal and external audits related to ERP system validation 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
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Specific requirements for this role
Experience:
Experience in validation and compliance of GxP regulated ERP systems including EDMS (Documentum-LSQM), EQMS Trackwise, and other ERP platforms
13-18 Years of domain experience.
Demonstrated ability to support audits and manage compliance risks effectively
Demonstrated Capability
Detail-oriented with strong analytical and problem-solving skills
Ability to manage multiple priorities, meet deadlines, and to meet quality norms
Skills and Capabilities
Experience in preparing and reviewing validation documentation and conducting ERP system qualification testing
Strong working knowledge of data integrity, good documentation practices, and regulatory requirements such as 21 CFR Part 11, EU Annex 11, and GAMP5.
Excellent communication and stakeholder management skills to work effectively across IT, QA, and business functions
Ability to mentor and train junior team members
Education
Master's degree in Science, Pharmacy, Biotechnology, B. Tech, or IT-related field
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.