Csv Consultant

Responsibilities:

• Conduct validation activities for laboratory and manufacturing systems, ensuring compliance with regulatory requirements and company standards.
• Perform gap analysis of existing systems to identify areas for improvement and ensure alignment with regulatory standards.
• Lead retrospective validation efforts to ensure legacy systems meet current regulatory expectations and industry best practices.
• Collaborate with cross-functional teams including Quality Assurance, IT, and Operations to develop validation protocols, test scripts, and validation plans.
• Execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems.
• Document validation activities, findings, and deviations according to standard operating procedures and regulatory guidelines.
• Provide expertise and guidance on computerized system validation principles, methodologies, and best practices.
• Participate in regulatory inspections and audits, providing support and documentation as required.
• Stay current with regulatory requirements and industry trends related to computer system validation.

Requirements:

• Bachelor's degree in Computer Science, Engineering, Pharmaceutical Sciences, or related field.
• 2 to 5 years of experience in computer system validation within the pharmaceutical industry.
• Strong understanding of regulatory requirements including FDA regulations (21 CFR Part 11, Annex 11) and GAMP 5 guidelines.
• Experience with lab and manufacturing systems validation is highly preferred.
• Proficiency in conducting gap analysis and retrospective validation activities.
• Excellent analytical and problem-solving skills with keen attention to detail.
• Ability to effectively communicate and collaborate with cross-functional teams.
• Experience in writing validation protocols, test scripts, and validation plans.
• Familiarity with document management systems and electronic record keeping.
• Willing to travel and work at client location