QA Specialist
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| Location: | Cork |
|---|---|
| Tags: | manufacturing | validation | engineering | |
| Type: | Contract |
Role:
+ Reporting to the Operations Leader, the QA Specialist will assist with the batch release process, and provide QA support on manufacturing and QC investigations.
+ Working within the process team you will be committed to continuous improvement, process understanding, lean manufacturing.
Responsibilities:
+ Assist with Manufacturing Batch record review.
+ Lead/ Assist with preparation of Quality systems, validation, and documentation.
+ Review and approve SOP's, and Validation protocol and reports.
+ Assist with regulatory inspections, development of cGMP training, and Regulatory Inspections.
Experience:
+ Third level qualification in Biological or Pharmaceutical Sciences, or Engineering
+ Proven experience of QA, Manufacturing, QC, Reg Affairs function of human pharmaceuticals or Bio pharmaceuticals.
+ Strong experience of U.S., E.U., and IMB regulations
+ All candidates must have excellent interpersonal skills, be strong team players, and be able to work off their own initiative.










