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Manager, Csv

6-7 years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Manager CSV – Life Sciences & Pharma Compliance (Thane)

Job Summary:
Cencora is seeking a highly skilled Manager CSV (Computer System Validation) with 6–7 years of experience in the pharmaceutical and life sciences domain. The role involves ensuring compliance with GxP, GAMP 5, and 21 CFR Part 11 standards, overseeing validation processes, risk assessments, and supporting audits. This is a full-time on-site role in Thane, Maharashtra, offering an opportunity to lead validation initiatives in a global healthcare company.


Key Responsibilities:

  • Plan, execute, and document CSV activities in compliance with internal and external regulations (GxP, GAMP 5, 21 CFR Part 11).

  • Collaborate with technology teams to review validation work and provide guidance or training.

  • Evaluate validation procedures and identify areas for improvement.

  • Ensure robust documentation and adherence to SOPs across all product validation processes.

  • Represent validation processes during external client audits.

  • Conduct risk assessments and provide best-practice recommendations for compliant system adoption.

  • Approve validation plans and ensure effective mitigation strategies are implemented.


Required Skills & Qualifications:

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related fields.

  • 6–7 years of experience in Computer System Validation (CSV) within the pharmaceutical industry.

  • In-depth knowledge of cGxP, GAMP 5, and 21 CFR Part 11 regulations.

  • Familiarity with software lifecycle and quality assurance practices.

  • Excellent communication and collaboration skills.


Perks & Benefits:

  • Competitive compensation aligned with industry standards.

  • Exposure to global pharmaceutical compliance and cutting-edge technologies.

  • Career growth opportunities in a multinational healthcare company.

  • Inclusive work environment with professional development programs.


Company Description:

Cencora, a global leader in healthcare and life sciences, is dedicated to improving patient outcomes worldwide. With a strong focus on pharmaceutical consulting, regulatory compliance, and innovation, Cencora empowers its team to create healthier futures through advanced solutions and expertise.


Work Mode: On-site – Thane, Maharashtra, India.


Call-to-Action:

If you have the expertise in computer system validation and want to advance your career with a global pharmaceutical leader, apply now by submitting your updated CV on the Cencora careers portal.