Responsibilities
- 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 3 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