QA Specialist - NPI
- Dublin
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
The main responsibilities for this 12 month contract position is the QA review, assessment and approval of Deviations/Investigations. This includes chairing the daily investigation meeting, issuing minutes from meetings, preparation of deviation metrics, participation at investigation Tier/huddle meetings etc.
Additional relevant responsibilities from the attached job specification are as follows;-
- Provide Quality oversight to support construction, qualification, validation, technical transfer, regulatory approvals and commercial operations
- Support the facility through NPI and into commercial biologics drug substance manufacture
- QA support for implementation of Manufacturing Execution System (MES)
- Co-ordination and support of the Deviations/CAPA system including evaluation, resolution and close-out
- Authoring, review and approval of QA-related procedures
- Supporting product documentation.
- Reviewing biologics and validation documentation for incoming products.
- Review SOPs, Protocols and other supported documentation on behalf of Quality all the way to batch release.
The candidate must have the rights to work in the location stated in the job advert.
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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
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
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