Csv Consultant

ProvenTech Pvt Ltd; Indor; On-site; INR 600,000 - 900,000; Full time

Job summary

ProvenTech Pvt Ltd is seeking a Computer System Validation specialist in the pharmaceutical sector to lead IQ/OQ/PQ activities, ensure compliance with FDA 21 CFR Part 11, Annex 11, and GAMP 5, and collaborate across QA, IT, and Operations.

You will validate lab and manufacturing systems, document findings, participate in regulatory inspections, and stay current with industry trends. Travel to client sites is required.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Pharmaceutical Sciences, or related field.
• 2–5 years of experience in computer system validation in pharma.
• Strong knowledge of FDA 21 CFR Part 11, Annex 11 and GAMP 5.
• Experience validating lab and manufacturing systems.
• Proficient in gap analysis and retrospective validation.
• Excellent analytical and communication skills.
• Willing to travel and work at client sites.

Responsibilities

• Conduct validation activities for laboratory and manufacturing systems.
• Perform gap analysis to identify areas for improvement and ensure regulatory alignment.
• Lead retrospective validation to meet current regulatory expectations.
• Collaborate with QA, IT, and Operations to develop validation protocols and plans.
• Execute IQ, OQ, and PQ for computerized systems.
• Document validation activities, findings, and deviations per SOPs.
• Provide guidance on validation principles and best practices.
• Support regulatory inspections and audits with required documentation.
• Stay current with regulatory requirements and industry trends.

Skills

Regulatory compliance

Validation planning

IQ/OQ/PQ execution

Documentation

Education

Bachelor's degree in Computer Science/Engineering/Pharmaceutical Sciences

Job description

NOTE: Notice Period (IMMEDIATE -15 DAYS)

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