Digitization lead

Job Title: Digitization Lead.  
Job Location: Syngene International Limited, Bengaluru 

About Syngene: Syngene (www.syngeneintl.com) 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 

1. 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 

2. 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.