Walk-in | Csv Consultant

ProvenTech Pvt Ltd; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

ProvenTech Pvt Ltd in Hyderabad, India seeks a Computer System Validation specialist with 4–5 years of pharma experience to lead validation activities for laboratory and manufacturing systems. You will perform gap analyses, lead retrospective validation for legacy systems, and collaborate with QA, IT, and Operations to draft validation plans and protocols.

The role requires IQ/OQ/PQ execution, thorough documentation, and active participation in regulatory inspections, while staying up-to-date

Qualifications

• Bachelor's degree in CS, engineering, pharma or related field.
• 4–5 years in computer system validation in pharma.
• Knowledge of FDA 21 CFR Part 11 and Annex 11; GAMP 5.
• Willing to travel and onsite client locations.

Responsibilities

• Conduct validation activities for lab and manufacturing systems.
• Perform gap analysis to identify areas for improvement.
• Lead retrospective validation for legacy systems.
• Collaborate with QA, IT, and Operations to develop validation plans.
• Execute IQ, OQ, and PQ for computerized systems.
• Document validation activities, findings, and deviations.
• Provide expertise on validation principles and best practices.
• Support regulatory inspections and audits.
• Stay current with regulatory requirements and trends.

Skills

Validation activities

Gap analysis

OQ/IQ/PQ execution

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in relevant field

Job description

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.


• 4 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