CSV and LIMS Manager

Job Title: LIMS & CSV Manager Job Location: Bangalore Department: Immunogenicity Research Laboratory About 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& productivity, speed up time to market and lower the cost of innovation. Job Purpose : The position holder is responsible for performing various tasks related to Computerized System Validation (CSV) which includes performing compliance related tasks provided as services from the department from developing plans, execute and deliver the services with acceptable service evaluations. Key Responsibilities: • Efficiently author/review yearly reports with respect to User Setup and Configuration Management • Experience in preparing master validation Plan/Report, Quality/Validation Plan/Report, IT Quality Risk Assessment and Qualification Protocol/Report • Prepare review and approve the following validation documentation, such as functional and technical design specifications like User Requirement Specification level, Installation Qualification Plan/Report, Operational Qualification Plan/Report etc. • Should be able to provide guidance to the IT System Subject Matter Expert on questions related to Computer System Validation Experience in test execution and reporting is required • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. • Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: • Master's degree in Life Sciences Technical/functional Skills: • Should have experience in performing Corrective Action Preventive Action and Root Cause Analysis • Should have experience in Computer System Validation and compliance process understanding • Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, Good Automated Manufacturing Practice (GAMP) Experience: • 1-3 years of total experience in Computerized System Validation (CSV). Behavioral Skills: • Should be independent. • Excellent communication skills - written and oral in English • Should have good interpersonal skills • Large degree of flexibility and ability to work under strong time pressure 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 accommodation for qualified individuals with disabilities.