Senior Executive

Job Description

The Senior Executive – CSV will be responsible for ensuring compliance of computerized systems with regulatory requirements (FDA, EU GMP, GAMP 5) through validation activities. This role involves planning, executing, and maintaining validation documentation for systems used in manufacturing, laboratory, and quality operations.

Key Responsibilities

• Develop and execute Validation Plans, Protocols (IQ/OQ/PQ), and Reports for computerized systems.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and other applicable regulatory guidelines.
• Perform risk assessments and impact analysis for new and existing systems.
• Coordinate with IT, QA, and vendors for system implementation and validation.
• Maintain validation documentation and ensure audit readiness.
• Support data integrity initiatives and periodic review of validated systems.
• Provide training and guidance on CSV processes to internal teams.
• Manage Applications implemented in QC, Manufacturing Warehouse also enterprise applicaitons (Initial diagnosis and user management)
  
  

Work Experience

mimimum 3–5 years in Computer System Validation within pharmaceutical and Quality Systems

Education

Graduation in Computer Science or Electronics

Diploma in Computer Science or Electronics

Competencies

Stakeholder Management

Strategic Agility

Customer Centricity

Innovation & Creativity

Collaboration

Result Orientation

Process Excellence

Developing Talent