Knowledgeable in 21 CFR Part 11, Annex 11, and GAMP 5

• Updates validation procedures, including change control, training, and audits, to ensure the maintenance of

system validation.

• Writes and reviews technical validation documents (e.g., validation plan, URS, FRS, Risk Assessment,

Traceability Matrix, IQ/OQ/PQ/OPQ protocol, report, etc.)

• Assists in system validation project activities (e.g., writing protocols, reviewing/approving test scripts, drafting

validation reports, etc.)

• Review and approve Change Control requests and assesses the impact on system validation status.

• Review and approve procedures, forms, and manuals.

• Perform audit trail reviews and document results.

• Perform system validation status evaluations and complete reports.

• Assist with supplier qualification assessment data gathering.

• Investigate, review, approve, and perform corrective actions for deviations (i.e., nonconformances and CAPAs)

and audit findings.

• Maintains the document management system for healthcare facilities and distribution centers to ensure

required documents and data are available for regulatory agency audits and inspections