Are you a CSV Specialist with experience in the pharmaceutical industry? Looking for a new permanent role?
My client, a leading pharmaceutical organization in North Carolina, is seeking talented CSV Engineers with strong QA experience to join their ambitious team. This is a fantastic opportunity to grow your career and make a significant impact in a dynamic environment.
Ready for your next challenge?
• Oversee all CSV Engineering activities, including task organization, prioritization, training, and conducting performance reviews.
• Provide IT CSV oversight for GXP computerized systems, utilizing a risk-based approach to validation and qualification in compliance with 21 CFR Part 11, EU Annex 11, and GAMP standards.
• Manage IT CSV-related deviations, CAPAs, and change controls for GXP computerized systems.
• Review and create validation documentation such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, and VSRs.
• Develop, test, and implement configurations, workflows, and reports to enhance the accuracy, efficiency, and effectiveness of electronic computerized systems.
• Identify and resolve system issues effectively, communicating critical items to senior management and stakeholders.
• Audit CSV for IT systems according to 21 CFR Part 11, Annex 11, and other regulatory requirements.
• Contribute to the development and enhancement of Quality Assurance programs, policies, processes, procedures, and controls to ensure compliance with cGMP and agency guidelines.
• Support the external audit program for vendors related to GXP computerized systems.
• Participate in cross-functional project teams.
• Interface with regulatory agencies as required, supporting regulatory inspections.
Requirements:
• 5 years of experience in Computer System Validation (CSV)
• Proven track record in pharmaceutical projects
• Extensive experience in a Quality Assurance (QA) environment
• Skilled in working with PLC-based systems
This is a fantastic opportunity to join a large pharmaceutical organisation in North Carolina.