This role is an 11 Month Contract with a view to extension.
To Generate & update, execute, review and approve Computer System Validation (CSV) documentation deliverables as part of a multi-disciplinary team of representatives responsible for Process Automation Remediation Plan delivery.
• Investigate and troubleshoot problems that 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 practices 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 the right-first-time approach.
• Ensure that any changes in detailed timelines are escalated promptly so that impacts can be proactively assessed and KPIs maintained.
• Bachelor’s Degree in Engineering, Information Systems, Computer Science, or the Life Sciences.
• At least 2 years of 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 of 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
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