Executive, CSV Quality

Job Responsibilities

• Develop and execute CSV deliverables: Validation Plan, User Requirements (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports.
• Perform system risk assessments to identify GxP impact and required validation.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, MHRA, ICH Q7/Q9 guidelines.
• Support audits and inspections (internal, regulatory, client).
• Collaborate with IT, QA, Manufacturing, and Business to ensure validation of ERP, LIMS, MES, CDS, QMS, and other GxP systems.
• Maintain validation documentation as per SOPs.
• Participate in Change Control, CAPA, and Deviation management related to computerized systems.
• Provide training and guidance on CSV processes and best practices.
• Contribute to transitioning from CSV to CSA (Computer Software Assurance) approach where applicable.

Technical Skills Required

CSV lifecycle and GAMP 5 guidelines : Advanced

21 CFR Part 11 and Annex 11 compliance : Advanced

Proficiency in writing validation documents (URS, FS, RA, IQ/OQ/PQ, VSR) : Advanced

SDLC (System Development Life Cycle) and risk-based validation: Advanced

Exposure to Computer Software Assurance (CSA) approach : Advanced

B-Pharmacy, M-Pharmacy