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Data Integrity Specialist

  1. Dublin
  1. Contract
Competitive
23620 JL
  1. Commisions, Qualification and Validation
Date Posted22 Oct 2019

This vacancy has now expired

Do you relish the opportunity to work with a leading Irish based Biologics manufacturer?  If yes, then this is the assignment for you!

Our biotech client with manufacturing facilities just outside Dublin, is currently investing significantly in their manufacturing programme.  Building a state-of-the-art facility, utilising high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. The site is easily reachable by a major airport and has excellent transport links throughout.

The client is currently seeking the expertise of a Data Integrity Specialist on a 12-month contract basis.

Working on their newly built Laboratories, you will be responsible for the following;
  •  Generation of the Data integrity system inventory which will serve as the living master list used to track all data integrity activities including any grouping strategies across the lifecycle for all data types.
  • Generate Data process maps in relation to all the data created, processed, reviewed, analysed, reported, transferred, stored, retrieved, monitoring and retired across each system
  • Conduct data risk assessments to assess the risk to data integrity and the reliance of product quality and GxP related decision on the quality of data.
  • Co-ordinate with the key stakeholders the completion of the data integrity assessments for each system or group of systems.
  • If required draft the gap remediation plans and associated mitigations for all potential gaps.
  • Track the closure of corrective actions to mitigate against the gaps.
  • Draft the data integrity execution schedule in alignment with the overall project schedule
If you have a background in Data Integrity implementation on pharma or biotech projects and want to work on a high-profile project, please apply today for immediate consideration.

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