CSV Analyst - Lab Equipment - New Build Biologics
Working within a new state of the art Biologics facility manufacturing you will be required to work as part of a team to assist with the CSV of over 200 pieces of new Laboratory equipment on site.
Analytical Laboratory equipment to qualify will include: Chromatography systems, Immuno assay equipment, TOC, FTIR, SpectraMax L & Karl Fischer Units.
Duties will include:
- Prepare CSV documentation for all global systems
- To prepare plans and protocols for CSV; Apply GAMP5 and ASTM2500 principles to project CSV
- Prepare Risk Assessments and quality assessments as required
- Provide guidance and technical skill knowledge to the site relating to automation System Life Cycle and computer system validation concepts
- Implementation of a CSV system to support new systems/equipment and upgrade leveraged systems/equipment
- Responsible for authoring, review, and/or approval of departmental Standard Operating Procedures (SOPs) specific to computer system validation activities
- Co-ordinates and manages all aspects of computer system validation projects, including the resolution or escalation of project-specific issues
- Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines.
- Degree qualified
- Experience of either biotechnology or pharmaceutical industry
- Prior AIQ analytical instrumentation experience within a Pharma / Bio environment
- Experience with GAMP5 & ASTME2500
- Analytical instrument qualification to include laboratory equipment but not limited Chromatography systems, Immuno assay development, TOC, FTIR etc.
- To be able to commit to an on-site interview in Dublin
- Be available max. of 4-6 weeks notice
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The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for Lab Validation Technicians
CSV Engineers are required to join a new build biotech facility, based in Meath. The validation engineer will be responsible for the completion of 21 CFR 11 assessments, creation/execution of IQ/OQ
New Build biologics facility have a contract requirement for an experienced Laboratory Equipment CQV Engineer to work on the qualification of the analytical equipment qualification. Working
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