レベル: Entry level

ジョブタイプ: Full-time

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仕事内容

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 (Write/Update/Withdrawn SOP, Procedures, Forms, Test script, Memo, etc…)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

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締切: 10-01-2026

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