Global IT QA

Overview

Provide QA governance for computer system validation (CSV) and electronic data integrity (eDI) across Centrient's global GMP systems, reporting to the Global QA Director CSV and Data Integrity.

What you'll do

• Provide QA governance to CSV and eDI practices for Global GMP systems (SAP, Trackwise, Master Control, Veeva and Infrastructure).
• Proactively participate in Global IT projects (new systems and changes) and 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.
• Act as System Subject Matter Expert on systems quality and validation.
• Organize trainings on CSV processes.
• Define and maintain the GMP compliancy audit agenda for the Centrient sites, business units and Qualified Vendors.
• Participate in relevant teams for all CSV and core business process projects to ensure necessary validation activities are identified and carried out.
• Participate and provide leadership and technical SME support to Global CSV and DI improvement projects.
• Participate in Corporate Audit (virtual and onsite) and for Computerized System audits.
• Provide IT CSV support for agency audits, including multiple international agencies at one time.
• Audit CSV and eDI for Local Sites, System Vendors, CMO, CLO and Global IT.
• Coach and train direct colleagues as well as Key-Users.
• Establish a computer system validation framework that is clear and effective for all stakeholders.

What you'll need

• 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.
• Good knowledge of GxP analysis, gap assessment and risk assessment.
• Good knowledge of 21 CFR Part 11, CSV – GAMP and electronic Data Integrity.
• Experience: 8 to 15 years.
• University degree in technical, science, chemical engineering or computer sciences.
• Independent, reliable and strong communication skills; team player; intercultural skills.

Details

• Location: Gurugram, Haryana, India.