Overview:

Our client, a prestigious pharmaceutical company, is seeking an experienced CSV QA Specialist with over 10 years of expertise in Computer System Validation (CSV) and 21 CFR Part 11 compliance. This role is critical in ensuring that computerized systems used in pharmaceutical manufacturing meet regulatory standards and function reliably.

Key Responsibilities:

• Computer System Validation (CSV): Lead and manage all aspects of Computer System Validation (CSV) to ensure compliance with industry standards and regulatory requirements.
• 21 CFR Part 11 Compliance: Ensure all computerized systems adhere to 21 CFR Part 11 regulations, maintaining data integrity, security, and electronic records management.
• Risk Assessment & Mitigation: Conduct thorough risk assessments on computerized systems and develop mitigation strategies to minimize potential compliance risks.
• Quality Assurance: Implement and maintain robust QA processes specific to CSV to ensure ongoing compliance and system reliability.
• Validation Documentation: Develop, review, and approve validation documentation, including validation plans, protocols, and reports.
• Cross-Functional Collaboration: Work closely with IT, Quality, and Regulatory Affairs teams to ensure all computerized systems are validated and comply with applicable regulations.
• Training & Support: Provide training and support to relevant teams on CSV processes and 21 CFR Part 11 requirements.

Key Requirements:

• Experience: Minimum of 10 years in a Quality Assurance role with a focus on Computer System Validation (CSV) and compliance with 21 CFR Part 11.
• CSV Expertise: Extensive knowledge and hands-on experience in CSV, including validation planning, protocol development, execution, and documentation.
• 21 CFR Part 11 Compliance: In-depth understanding of 21 CFR Part 11 regulations and their application in the pharmaceutical industry.
• Regulatory Knowledge: Strong understanding of regulatory requirements related to computerized systems in pharmaceutical manufacturing.
• Leadership: Proven ability to lead CSV projects, manage cross-functional teams, and ensure successful validation of complex systems.

Why Join Us?

• Industry Leader: Work with a leading pharmaceutical company that values innovation, quality, and compliance.
• Challenging Role: Take on a key role in ensuring that our computerized systems meet the highest standards of quality and regulatory compliance.
• Career Growth: Enhance your expertise in CSV and 21 CFR Part 11 while contributing to the success of a dynamic and forward-thinking organization.

Apply Now:
If you are an experienced CSV QA Specialist with a passion for ensuring compliance and system reliability, we encourage you to apply. Join our client in their mission to maintain the highest standards of quality in pharmaceutical manufacturing.