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Computer Systems Validation
4 weeks ago
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
DeltaV
Pharmaceutical Industry
Manufacturing Engineering
Emerson DeltaV
Risk Assessment
Regulatory Compliance
GMP
Traceability
PLC
Strategy
SCADA
Compliance
LIMS
Siemens S7
Change Control
Life Science Industry
Siemens PLC
BMS
