QA Validation Consultant

Job Description:

In this Position of IT Quality Assurance Associate, you will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements.

Responsibilities:

• Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.
• Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to 21CFR Part 11 Compliance and other relevant regulations.
• Review, and approve CSV lifecycle documents, including validation plans, requirements, risk assessments, and validation summary reports.
• Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
• Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.

Requirements:

• Bachelor's degree in computer science, Information Technology, Life Sciences, or a related field
• Minimum of 4 years of direct experience in validation in pharmaceutical, biotechnology, or regulated healthcare industry
• Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21CFR Part 11 compliance.
• Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.
• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
• Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.
• Detail-oriented with a strong analytical mindset and problem-solving capabilities.