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Medium due to metro location and mid-level experience, while niche CSV expertise reduces applicant density.
High because CSV/GxP regulatory skills and validation experience are specialized to pharmaceutical life-sciences.
High due to explicit 6-year CSV requirement and mandatory regulatory and documentation expertise.
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Own and review key Computerized System Validation (CSV) deliverables for GxP products in pharmaceutical IT compliance, including URS, Validation Plan, Test Plan, and Traceability Matrix.
Collaborate with SMEs for requirements analysis, risk assessment, and review qualification scripts (IQ, OQ, PQ) related to software categories in drug safety domain.
Support internal and client audits, assist in quality investigations and CAPAs, and guide product/project teams on CSV impact for change controls.
6 years hands-on experience in computerized system validation within pharmaceutical/life sciences/medical devices industry.
Degree in BE/B.Tech./MCA/B.Pharma/M.Pharma from a recognized institute with good academic record.
In-depth knowledge of regulatory guidelines (FDA, EMA, MHRA, PMDA) and compliance standards (21 CFR Part 11, EU Annex 11).
Experience with IT Quality Management System (IT-QMS), audit experience on IT systems, and expertise in reviewing CSV documentation.
Strong expertise in pharmaceutical IT Compliance focusing on drug safety and GxP environment, with proven ability to manage CSV documentation and audit support.
Experienced in interacting with clients and guiding teams on CSV procedures and change control impacts in regulated IT environments.
Detail-oriented with strong organizational skills, capable of prioritizing multiple tasks while balancing quality and productivity.