Laboratory Equipment Qualification Specialist - 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 qualify 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:
- You will be involved in the development of the URS's & Risk Assessment documentation and drafts of IQ/OQ/PQ as well as execution
- Review and communication of instrument qualification in a concise, organized, and compliant manner
- Author SOPs and training documents
- Provide quality oversight and ensuring GMP compliance for engineering and validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, engineering design, qualification, process validation and change management
- Responsible to review and approve validation protocols, reports, procedures and other related documents to ensure compliance
- Degree qualified
- Experience of either biotechnology or pharmaceutical industry
- Experience with IOQ protocol generation, review and execution
- 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
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
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
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Wendy
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