CSV Validation Expert
We are looking for an experienced CSV Validation Expert to join our team. The ideal candidate will have strong knowledge of computer system validation, GxP regulations, and industry best practices.
Key Responsibilities:
Develop and execute CSV documentation for various systems
Ensure compliance with FDA, EMA, and other regulatory requirements
Conduct risk assessments and gap analysis for computer systems
Collaborate with cross-functional teams for validation activities
Provide training and mentorship to junior team members
want to be good in job
Requirements:
Bachelor's or Master's degree in Pharmacy, Engineering, or related field
5+ years of experience in CSV within pharmaceutical industry
Strong knowledge of GAMP 5, 21 CFR Part 11, and Annex 11
Experience with ERP, LIMS, and laboratory systems validation
wantbto be good in job