Work with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
Schedule, organize and coordinate at detailed site level, validation activities with cross functional groups
Assist in raising Change Control to update Automation System Life cycle documentation, SOPs, Risk Assessment, Requirement Traceability Matrix etc.
Review and approve of validation protocols, reports and deliverables for the specialized validation area
Define requirements for validation activities and ensure regulatory compliance based on Risk Assessment
Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier
Review and check documentation for GMP compliance
Collaboration and or Creation of Validation summaries
Requirements
Degree in Engineering/Pharmaceutical/Computer Science or related studies
At least 10 years of experience in a CSV role within the pharmaceutical industry is a must.
Good fundamental technical knowledge of automation system such as Siemens PCS7, DeltaV or IT system to assist automation engineers in developing life cycle documentation.
Knowledgeable in GAMP5, ANSI/ISA-88 and 21 CFR PART 11 requirements
