Data Integrity Specialist
- Dublin
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
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
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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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