Computerized System Validation (CSV)

Responsibilities

• Conduct validation activities for laboratory and manufacturing systems, ensuring compliance with regulatory requirements and company standards.
• Perform GAP ASSESSMENT / GAP ANALYSIS of existing systems to identify gaps, 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 Quality Assurance, IT, and Operations teams to develop validation protocols, test scripts, and validation plans.
• Execute validation protocols including DQ, IQ, OQ, and PQ for computerized systems.
• Document validation activities, findings, deviations, and gap assessment results according to SOPs and regulatory guidelines.
• Provide expertise and guidance on Computerized System Validation (CSV) principles, methodologies, and best practices.
• Participate in regulatory inspections and audits, providing required support and documentation.
• Stay current with regulatory requirements and industry trends related to CSV.

Requirements

• Bachelor's degree in Computer Science, Engineering, Pharmaceutical Sciences, or related field.
• 2-8 years of experience in Computerized System Validation (CSV), preferably within the pharmaceutical industry.
• Strong understanding of 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Experience with laboratory and manufacturing systems validation is highly preferred.
• Strong experience in GAP ASSESSMENT / GAP ANALYSIS and retrospective validation activities.
• Experience in identifying, documenting, assessing, and resolving compliance gaps in computerized systems.
• Experience in writing validation protocols, test scripts, validation plans, and gap assessment reports.
• Experience with DQ, IQ, OQ, and PQ.
• Excellent analytical and problem-solving skills with keen attention to detail.
• Ability to communicate and collaborate effectively with cross-functional teams.
• Familiarity with document management systems and electronic record keeping.
• Willingness to travel and work at client locations.

• Note: Hyderabad location where they have to work from Jadcherla plant location