GMP Scientific Data Reviewer - Gene Therapy

We are seeking Data Reviewers to join our growing Gene Therapy team in Dungarvan Co Waterford. A hybrid working pattern can be considered for this role with a maximum of 2 days a week from home after the initial training period.

3+ years' GMP Pharma experience is required to apply for this role. 

The purpose of this job is the data review of scientific test procedures used on client samples ensuring that accurate results have been produced. This person will also work to develop any ancillary procedures associated with the processes used; ensuring customer samples are completed within their required specifications. 

Responsibilities 

• Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.
• Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.
• Data Reviewers are permitted to sign all technical documents within the company once their training in this task is successfully completed.  This includes laboratory reports, SOPs, protocols, investigation reports and any other documentation issued.
• This person will perform analytical testing when not engaged in Data Review activities. 
• This person will ensure that all documentation is completed on time, accurately and legibly.
• Responsible for updating any relevant documentation as required.
• Responsible for handling any customer related queries where necessary and liaising with their team to problem solve these queries if needed.
• To keep their training records up to date and to initiate training as per their training plan where possible when free from work
• To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
• To ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
• To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement