Computerized System Validation (CSV)

Mytech; Indore District, Hyderabad, Bengaluru; On-site; INR 1,500,000 - 2,800,000; Full time

Job summary

Mytech in India is seeking a qualified CSV specialist to validate laboratory and manufacturing systems in line with 21 CFR Part 11, EU Annex 11, and GAMP 5. You will lead GAP assessments, retrospective validation, and develop validation protocols, scripts, and plans, collaborating with QA, IT, and Operations. Travel to client sites will be required.

The role emphasizes documenting deviations, keeping compliant with SOPs, and supporting regulatory inspections while staying current with CSV trends.

Qualifications

• Bachelor's degree in CS/Engineering/Pharma or related field.
• 2-8 years of experience in Computerized System Validation (CSV).
• Knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Experience with laboratory and manufacturing systems validation.
• Strong GAP ASSESSMENT / GAP ANALYSIS and retrospective validation experience.
• Experience in writing validation protocols, test scripts, and validation plans.
• DQ, IQ, OQ, and PQ experience.
• Able to document compliance gaps and deviations.
• Willingness to travel and work at client locations.

Responsibilities

• Conduct validation activities for laboratory and manufacturing systems per regulatory standards.
• Perform GAP ASSESSMENT / GAP ANALYSIS to identify gaps and improvement areas.
• Lead retrospective validation to ensure legacy systems meet current expectations.
• Collaborate with QA, IT, and Operations to develop validation protocols and plans.
• Execute DQ, IQ, OQ, and PQ for computerized systems.
• Document activities, deviations, and gap results per SOPs and guidelines.
• Provide CSV guidance on principles and best practices.
• Support regulatory inspections and audits with required documentation.
• Stay updated on regulatory trends in CSV.

Skills

Validation expertise

Analytical skills

Cross-functional collaboration

Regulatory compliance

Problem solving

Communication

Education

Bachelor's degree in Computer Science, Engineering, Pharmaceutical Sciences, or related field

Job description

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