CSV Specialist

Bahwan CyberTek

6 - 10 years

18 - 27 Lacs

pune chennai bengaluru

Posted:19 hours ago| Platform:

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Skills Required

life sciences gamp computer system validation gxp lims alm jira cfr

Work Mode

Hybrid

Job Type

Full Time

Job Description

Key Responsibilities:

Lead and execute CSV activities for Veeva Vault applications, including integration, configuration, and reporting modules.
Develop and maintain validation documentation in alignment with GAMP-5, GxP, and 21 CFR Part 11 requirements.
Collaborate with cross-functional teams (ITQ, Business) to ensure end-to-end validation of system changes and integrations.
Utilize Application Lifecycle Management (ALM) and Jira for requirement management, test planning, and execution.
Handle Change Management processes: Assess impact of changes, update validation documentation, and ensure compliance with SOPs and regulatory standards.

Required Skills & Qualifications:

Bachelors degree in Computer Science, Engineering, Life Sciences, or related field.
68 years of experience in CSV within pharmaceutical or life sciences domain.
Hands-on experience with Veeva Vault (integration, configuration, reporting).
Strong understanding of GxP, GAMP-5, 21 CFR Part 11, Annex 11, and data integrity principles.
Proficiency in ALM and Jira tools.
Excellent documentation skills and attention to detail.
Strong communication and stakeholder management skills.

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