Generate/ update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of site representatives responsible Process Automation Remediation Plan delivery.
- Generate/ update, execute, review and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery.
- 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.
- Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI’s maintained.
- 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).
- Experience in PLC/SCADA/DCS systems
To apply contact Martin Lynch on 087-344 3581.
Email CVs to firstname.lastname@example.org
|Job Category||Process Automation CSV|