Description

Validate systems and processes to ensure compliance with GxP standards and regulatory requirements.

This role is on-site.

Responsibilities

• Collaborate with stakeholders to collect and document business and system requirements.
• Translate business needs into functional specifications, use cases, and technical documentation.
• Develop and maintain validation artifacts including URS, FS, and validation protocols.
• Analyze current RBQM processes and identify areas for improvement.
• Ensure all RBQM-related processes and systems adhere to GMP, GLP, and GCP standards.

Required Skills

• 5+ years of professional experience in validation or quality engineering.
• Working knowledge of GxP standards including GMP, GLP, and GCP.
• Familiarity with Risk-Based Quality Management (RBQM) processes and requirements.
• Ability to facilitate User Acceptance Testing (UAT).
• Experience translating business requirements into technical specifications.
• Strong documentation skills for URS, FS, and validation protocols.
• Bachelor’s degree or equivalent graduate education.

Key Skills

Education

Any Gradute