CQV Engineer (Packaging)
- NI & Ireland
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
While the role will primarily support the packaging plant there may be an opportunity to work within the Bulk Drug Substance facility also
Essential Duties and Responsibilities for this CQV role include, but are not limited to, the following:
- Ensuring adherence to CQV procedures during the CQV execution phase
- Support CQV leads with matters relating to Commissioning Engineering Change Control.
- Generate, Execute, Review and Approve CQV documentation as necessary Liaise with CQV area leads, Quality and Design SMEs on preparation and execution of significant deviations.
- Carry out regular Audits on all matters relating to CQV Verification documentation execution.
- Execute technical and GDP review on executed Commissioning Verification documentation.
- Creation & agreement of dry-run examples of executed CQV VTSs.
- Understanding and applying industry specific compliance standards/regulations to all CQV activities.
- Leading Risk assessments, root cause analysis and investigations.
- Review of protocols, reports, project change controls and deviations.
- Proactively highlighting any issues around compliance.
- Commissioning, qualification and validation experience and / or Quality Assurance experience in a Packaging plant
- Experience in bioprocess manufacturing experience in an established biotech production operation.
- Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
- Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
- Experience in IMB/FDA environment advantageous.
- Good general knowledge on Quality, cGMPs, ICH and ISOStrong technical writing and communication skills.
To be considered for this position, please apply with a copy of your up to date CV!
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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