Generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team.
- Generate/ update, execute, review and approve Computer System Validation (CSV) deliverables in line with the AIQ Remediation Plan delivery.
- The CSV Engineer will investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
- Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
- Provide technical support for the development of electronic data review procedures
- Actively manage the execution of all CSV testing with right first time approach.
- The CSV Engineer will ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained.
- At least 2 years experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
- A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
- Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments).
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