Hetero Drugs Ltd
Write, maintain, review and design specifications (URS/ FS/ DS), Protocols (IQ/ OQ/ PQ/ CSV), Validation Plans, Qualification Plans, System Level Impact Assessments, Component Level Impact Assessments, GxP Assessments, Traceability Matrices, Risk Management Plans, Validation Summary Reports, Quality Systems (Change Control, Non – Conformances, Re – qualification).
Responsible for planning, managing, and executing the Computer System Validation oversight program of computerized systems, including reviewing and approving computerized system validation documentation and IT change controls for compliance with 21 CFR Part 11, EU Eudralex Vol 4 Annex 11 and GAMP 5 principals/life cycle concept.
Facilitates and leads Validation process improvements and readiness initiatives related to electronic system development life cycle, validation processes, IT systems/ processes, data integrity control processes, and regulatory compliance processes.
Issue Management and CAPA (Corrective Action and Preventative Action) documentation and execution.
Experience in Agile Methodology.
Reference Id: SE – CSV
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