Open Position OT CSV Engineer

Belgium, Verviers

Quality is one key activities within the OT department. Data Integrity aspect is now part of our responsibilities and need to be handle by a Computer System Validation Engineer person. (CAPA, Deviation, ... New project, Data Integrity leader role for the site).

Missions:

  • Write qualification/validation documents activities for the OT equipment/system/computer system during their entire lifecycle (e.g. GMP/Non-GMP classification, URS & SOP, Data Integrity risk assessment, new OT equipment qualification/modification/planned revalidation, decommissioning validation activities.)
  • Perform OT Quality and Validation roles in the Change Control system to assure the changes are implemented following the established procedures.
  • Management and follow-up the day-to-day quality activities (Change Control, Deviations, Global Observations, CAPA, others.) and participate to the quality meeting to represent the OT department.
  • Performs audit trail´s data integrity risk assessments as per current policies.
  • Act as OT Quality Specialist (SME and Quality point of contact) during project implementation.
  • Ensure the compliance of the local qualification/validation activities
  • with Lonza Corporate requirements/standards/current regulatory requirements.
  • Maintains appropriate independence to ensure that there is no conflict of interest between regulatory requirements and day-to-day operational priorities.
  • Manage Quality documentation of OT department with the help of Internal OT System Admin expert. (Write/Update/Withdrawn SOP, Procedures, Forms, Test script, Memo, etc…)
  • Handle the Role of Date Integrity Leader of Lonza Verviers and represent the site for all Data Integrity Aspect.

Education:

Diploma in higher education (degree type) or university : Scientific (biology, chemistry, microbiology,engineering

Work experience:

Quality, Data Integrity

Reference: R43517