What are the responsibilities and job description for the QA Validation Consultant position at Katalyst CRO?
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
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.
- 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.
