Manager - Computer System Validation

About the Role

This position demands 10 to 16 years of comprehensive experience in Computer System Validation (CSV) within a regulated pharmaceutical environment. The ideal candidate will possess extensive knowledge of regulatory standards such as 21 CFR Part 11, GAMP 5, Annex 11, and Data Integrity. The role centers on overseeing CSV activities across ERP, LIMS, QMS, LMS, SAP, and various laboratory and manufacturing computerized systems to ensure regulatory compliance and uninterrupted business operations.

Key Responsibilities

• Validate ERP, LIMS, QMS, LMS, SAP, laboratory systems, manufacturing systems, and infrastructure qualifications.
• Lead CSV lifecycle activities including creating and managing User Requirement Specifications (URS), Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), validation protocols, and reports.
• Work collaboratively with Quality Assurance, Information Technology, Engineering, Manufacturing, and Regulatory teams to maintain compliance and support business continuity.
• Manage and prepare for regulatory audits and inspections from authorities such as USFDA, MHRA, and EU-GMP.
• Demonstrate strong project management skills coupled with stakeholder and vendor coordination.
• Handle change control, incident management, Corrective and Preventive Action (CAPA), and periodic reviews effectively.
• Apply practical knowledge of SAP/ERP systems, IT infrastructures, and pharmaceutical automation platforms.
• Manage multiple concurrent projects within a fast-paced, compliance-focused environment.

Qualifications and Skills

• Any Graduation or Engineering degree in IT, Computer Science, or a related field.
• 10 to 16 years of pertinent experience in IT-CSV specifically within the pharmaceutical industry.
• Experience working in USFDA and EU-compliant pharmaceutical manufacturing facilities is desirable.
• Exposure to digital transformation projects and computerized quality management systems is preferred.