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QA Specialist - NPI

  1. Dublin
  1. Contract
  1. Compliance / Quality Assurance
Date Posted22 Jan 2020

This vacancy has now expired

QA Specialist required to support a global biotech company for a 12 month contract to focussed on the new product introduction and technical transfer of products into site.

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;-
  1. Provide Quality oversight to support construction, qualification, validation, technical transfer, regulatory approvals and commercial operations
  2. Support the facility through NPI and into commercial biologics drug substance manufacture
  3. QA support for implementation of Manufacturing Execution System (MES)
  4. Co-ordination and support of the Deviations/CAPA system including evaluation, resolution and close-out
  5. Authoring, review and approval of QA-related procedures
Previous experience
  1. Supporting product documentation.
  2. Reviewing biologics and validation documentation for incoming products.
  3. Review SOPs, Protocols and other supported documentation on behalf of Quality all the way to batch release.
 If this is you please apply today.

The candidate must have the rights to work in the location stated in the job advert.

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