Intas Pharma opens for Computerized System Validation

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.

Post : Manager, IT (Computerized System Validation)

Qualification : Bachelor's or Master's degree in Pharmacy, Science, Computer Science, or related fields, with experience in regulated pharmaceutical environments.

Role description : The Manager - IT CSV is responsible for end-to-end oversight of Computerized System Validation (CSV), equipment/utility qualifications, audit support, and quality systems compliance in a GxP-regulated pharmaceutical environment. The role ensures adherence to global regulatory expectations, ALCOA+ principles, data integrity standards, and Quality Risk Management (QRM) practices. This position requires strong coordination with cross-functional stakeholders across IT, QA, Engineering, Business functions, and external vendors.

Key Responsibilities :
• Review and approve key CSV deliverables (RS, VP, FRS, SDS, CS, Test Plans, IQ/OQ/PQ, Traceability Matrix, Data Migration, Hypercare, VR).
• Ensure CSV activities comply with SDLC, GxP, and regulatory expectations.
• Lead qualification activities (URS, FAT/SAT, IQ/OQ/PQ, Water System, HVAC, Compressed Air).
• Apply risk-based and QRM principles across CSV and qualification processes.
• Ensure end-to-end data integrity compliance (ALCOA+).
• Maintain GxP-aligned documentation and system controls.
• Coordinate with IT, QA, Engineering, Manufacturing, Packaging, Business Teams, and Vendors.
• Prepare, review, and update SOPs related toCSV, qualification, and data integrity.
• Support internal/external audits; ensure timely CAPA closure and inspection readiness.
• Perform impact assessments and manage change controls.
• Investigate and manage GxP incidents and system-related deviations.
Responsible for end-to-end validation of computerized systems

Key Skills :
• Strong expertise in CSV, SDLC, GxP, CFR, Data Integrity (ALCOA+), and QRM.
• Hands-on experience in equipment and utility qualifications.
• Excellent documentation, compliance, and audit-handling skills.
• Strong communication, stake holder coordination, and problem-solving abilities.
• Ability to manage multiple validation projects independently.