Description

Lead Computer System Validation (CSV) and change control processes to ensure regulatory compliance for GxP systems.

Manage CSV and Computer System Change Control processes using risk-based methodologies. Conduct GxP evaluations for new computer and instrument systems, including cloud-based solutions and SaaS tools. Review and approve CSV lifecycle documentation, system-specific administration SOPs, and user access reviews. Oversee formal test execution and vendor qualification documentation to ensure compliance. Act as the QA CSV Subject Matter Expert during audits and regulatory reviews.

Responsibilities

• Manage risk-based CSV and change control processes for GxP environments.
• Evaluate and validate cloud-based solutions, SaaS tools, and GLP instrument systems.
• Review and approve validation documentation, SOPs, and user access reviews.
• Oversee formal test execution and vendor qualification.
• Serve as the Subject Matter Expert during regulatory audits.

Required Skills

• 10+ years of experience in electronic-based Computer System Validation within a GxP environment.
• Proven experience validating cloud-based computer solutions and GxP SaaS tools.
• Deep knowledge of the full software development life cycle (SDLC).
• Expertise in authoring, reviewing, and executing validation documents and test scripts.
• Hands-on experience with eDMMS tools such as Documentum or Master Control.
• Proficiency with testing tools including Jira and ALM.
• Strong project management experience for regulatory projects.
• Bachelor's degree or equivalent formal academic qualification.

Preferred Skills

• Experience with ValGenesis, Kneat, TX3, or First Doc.
• Knowledge of GAMP and CAPA processes.

Key Skills

Education

Bachelor's degree