Global IT QA

Key Individual Accountabilities:-

• Provide QA governance to CSV and eDI practices for Global GMP systems
• Proactively participate in Global IT projects (new systems and changes)
• Proactively participate in Global IT quality improvement projects
• Ensure Change Control governance in line with processes and stakeholders such as Local site QA, IT and respective

Business Owners

• Acts as System Subject Matter Expert on systems Quality and Validation
• Organize trainings on CSQ processes
• Define and maintain the GMP compliancy audit agenda for the Centrient sites and business units and Qualified Vendors

Key Shared Accountabilities :-

• Participate in relevant teams for all CSQ and core business process projects to ensure that the necessary validation activities are identified and carried out
• Participate and provide leadership and technical SME to Global CSV and DI improvement projects
• Participate in Corporate Audit (Virtual and On site) and for Computerized System
• Provide IT CSV support for agency audits including multiple international agencies at one time

Key Leadership behaviors:-

• Communicates effectively with a diverse audience
• Ability to lead and manage project teams
• Great team player
• Fast learner
• Open and value / result oriented
• Intercultural skills

Owns & Influences

Compliance of Global IT systems to applicable

regulation

• External inspection & audit support
• Audit planning, execution, reporting and monitoring

Establish a computer system validation framework that is clear and effective for all stakeholders involved in projects and day to day operation and maintenance

Requirements

Required Competencies:-

• Working knowledge of Global IT systems (SAP, Document Management System, CAPA Management Systems)
• Strong Quality and continuous improvement mindset
• Deep expertise in Computer System Validation and Data Integrity for the Pharmaceutical industry
• Independent and reliable worker
• Team player
• Strong communications skills
• Intercultural skills
• Good Knowledge of GxP Analysis, Gap Assessment, Risk Assessment
• Good Knowledge of 21 CFR Part 11, CSV - GAMP and electronic Data Integrity

Experience : 8yrs. to 15 yrs.

Education:-

University degree in technical, science, chemical engineering or computer sciences