Syngene Life Science Position – MSc Candidates Apply Online
Title: Senior Executive
Date: 7 Feb 2025
Job Location: Bangalore
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 worldwide. 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 4,240-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.
Job Purpose:
The position holder is responsible for performing various tasks related to Computerized System Validation (CSV), which includes compliance-related tasks provided as services from the department, developing plans, executing, and delivering 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 validation documentation, such as functional and technical design specifications like User Requirement Specification level, Installation Qualification Plan/Report, and Operational Qualification Plan/Report.
- Provide guidance to the IT System Subject Matter Expert on Computer System Validation questions.
- 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 by the company.
Educational Qualification:
- Master’s degree in Life Sciences
Technical/Functional Skills:
- Experience in performing Corrective Action Preventive Action (CAPA) and Root Cause Analysis (RCA).
- Experience in Computer System Validation (CSV) and compliance process understanding.
- Knowledge and experience with regulatory requirements such as OECD, GXP, 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP).
Experience:
- 1-3 years of total experience in Computerized System Validation (CSV).
Behavioral Skills:
- Should be independent.
- Excellent written and oral communication skills in English.
- Should have good interpersonal skills.
- High degree of flexibility and ability to work under strong time pressure.
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