Open Position OT CSV Engineer
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).
- 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 (Write/Update/Withdrawn SOP, Procedures, Forms, Test script, Memo, etc…)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.
Diploma in higher education (degree type) or university : Scientific (biology, chemistry, microbiology,engineering
Quality, Data Integrity