Elevate your career as an IT Validation Specialist at Neopharm Labs and ensure compliance in health product development. Utilize your validation knowledge in a collaborative team.
The position focuses on validating laboratory systems through rigorous planning and execution, ensuring compliance with GxP regulations. You will develop validation protocols, assess system changes, and maintain SOPs related to computerized systems. Your ability to provide insights during audits and inspections will be pivotal in fostering compliance with evolving regulatory demands in the life sciences sector.
Key Responsibilities:
• Validate GxP-impacting computerized systems
• Author validation plans and protocols
• Perform regulatory and guideline surveillance
• Collaborate with QA and IT teams
• Prepare validation reports and recommendations
Requirements:
• Over 5 years in a regulated environment
• Minimum of 3 years in CSV
• Expertise in ISPE GAMP 5 and PIC/S guidelines<...