Description

Own validation activities and compliance assessments within life sciences environments.

This role is remote.

Responsibilities

• Execute validation coverage including IQ and OQ protocols.
• Perform Functional Risk Assessments and GxP assessments.
• Conduct 21 CFR Part 11 and risk-based validation assessments.
• Manage data migration and disaster recovery qualifications.
• Oversee qualification and commissioning processes.

Required Skills

• 11-12 years of experience in Life Sciences and Computer System Validation (CSV).
• Hands-on experience with Oracle Agile PLM, Serialization, Oracle EBS, or SAP.
• Deep understanding of GAMP 5 principles.
• Expertise in Risk-Based Validation methodologies.
• Proven experience with 21 CFR Part 11 compliance.
• Experience with data migration and disaster recovery qualification.
• Any graduate degree.

Key Skills

Education

Any graduate