CSV

Designation:  Computerized System Validation (CSV) 

Job Location: Bangalore

Reporting to:

Job Grade:

The Company

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas

Role-specific:

• Execute validation of computerized systems in compliance with regulatory standards and internal procedures and ERES (Electronic Records and Electronic Signature) validation efforts.
• Prepare, review, and approve validation deliverables (URS, SLIA, DQ, validation protocols, reports), and supporting documentation in collaboration with QA and operations teams.
• Always ensure safety and data integrity compliance.
• Should provide data and maintain the SQDECC and other operational excellence activities.
• 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

Education and Experience

Education

Bachelor’s or master’s degree in Life Sciences, engineering, or related field.

Industry Experience

Minimum 5 years of relevant practical experience in a GMP organization (pharma, biopharma/biotech) with 2+ years of experience as lead in CSV, CQV, or related operational or compliance roles within the (bio)-pharmaceutical industry.

Other competencies required for the role 

• Proven track record in successful completion of CSV projects and experience with risk-based validation approaches and data integrity principles as per GAMP guide.
• Strong knowledge of regulatory requirements (e.g., 21 CFR Part 11, EU GMP Annex 11).
• Excellent written and verbal communication skills for regulatory documentation and presentations.
• Proficiency in technical documentation and audit readiness.
• Strong interpersonal skills with ability to work with internal and external stakeholders.

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.

Pls visit us at https://syngeneintl.com/ to know more about us, and what we do.