Job highlights

- Bachelor's degree with 2-5 years in computer system validation in pharma, expertise in FDA regulations (21 CFR Part 11, Annex 11) and GAMP 5

- Conduct validation activities for lab and manufacturing systems, perform gap analysis, lead retrospective validation, develop and execute validation protocols, support audits and inspections

NOTE: Only need candidates who can join on 2nd Nov or before

LOCATIONS: Hyderabad, Indore and Bangalore

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.

- Robust 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

📌 Csv Consultant (Indore)
🏢 Proventech
📍 Indore