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
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.