NextGen IT Labs
Qualifications
Expertise in 21 CFR Part 11, Annex 11, and GAMP 5 compliance
Experience updating validation procedures (change control, training, audits)
Ability to write and review technical validation documents:
Validation Plan
URS, FRS
Risk Assessment, Traceability Matrix
IQ/OQ/PQ protocols and reports
Responsibilities
Support system validation project activities: Writing protocols
Reviewing/approving test scripts
Drafting validation reports
Review and approve Change Control requests and assess impact on validation status
Review and approve procedures, forms, and manuals
Perform audit trail reviews and document results
Conduct system validation status evaluations and complete reports
Assist with supplier qualification assessment data gathering
#J-18808-Ljbffr
Expertise in 21 CFR Part 11, Annex 11, and GAMP 5 compliance
Experience updating validation procedures (change control, training, audits)
Ability to write and review technical validation documents:
Validation Plan
URS, FRS
Risk Assessment, Traceability Matrix
IQ/OQ/PQ protocols and reports
Responsibilities
Support system validation project activities: Writing protocols
Reviewing/approving test scripts
Drafting validation reports
Review and approve Change Control requests and assess impact on validation status
Review and approve procedures, forms, and manuals
Perform audit trail reviews and document results
Conduct system validation status evaluations and complete reports
Assist with supplier qualification assessment data gathering
#J-18808-Ljbffr