Global IT QA

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.

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