CSV Analyst - Lab Equipment - New Build Biologics
- Dublin
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
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
Call me for further information on this role!
The candidate must have the rights to work in the location stated in the job advert.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
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Wendy
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