Generate/ update, execute, review and approve CSV documentation deliverables as part of a multi-disciplinary team of the site representatives responsible for Analytical Instrument Qualification (AIQ) Alignment/Remediation Plan delivery.
- Execution/Review/Approval of test protocols using the Kneat system.
- Assess existing validation testing to ensure compliance to internal Quality Standards and expectations.
- Investigate, raise, review, and approve testing defects/change controls and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
- Work with the system owners, IT 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 (including audit trail) 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.
- Act as the validation SME for analytical systems.
Qualifications & Education
- Experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
- Hands on experience and a thorough knowledge of Laboratory based computerised systems.
- 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 use of Kneat E-validation software is desirable.
To apply contact Martin Lynch on 087-344 3581.
Email CVs to firstname.lastname@example.org