Purpose of the Role:-

Reporting to the Global QA Director CSV and Data Integrity, providing governance and services to Global IT and supporting the global audit programme. Ensure global GMP applications (SAP,

Trackwise, Master Control, Veeva and Infrastructure) compliance with CSV and Data Integrity best practice according to applicable regulations and Corporate Policy and Procedure.

Work with partners in Global IT to ensure that new projects and changes are executed to maintain the validated state.

Apply GMP & cGMP as meant by 21 CFR part 11, EU GMPs Annex 11, GAMP and current eDI best practice. Ensure embedding of Quality and Validation in the total approach, thinking and

acting. Coach and train direct colleagues as well as Key-Users. Audit CSV and eDI for Local Sites, System Vendors, CMO, CLO and Global IT.

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