Senior QA Regulatory Specialist

Posted on: 03/02/2020
Ref: VAC-17999
 
  • Country: Ireland
  • Location: Cork
  • Industry: Quality Assurance
  • Discipline: Quality Assurance
  • Employment Type: Contract
  • Duration: 51 weeks+

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Job Description

LSC have a great contract opportunity a Senior QA Specialist to join a leading biotech company based in Cork!

ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Point of Contact to request, source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, Deviations, Quality Agreements) to support miscellaneous regulatory requests such as paper-based inspections (e.g. Taiwan, Japan etc).
o In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses
o Notarization and legalization management.
o In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests.
o Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the JSI sections are accurate and consistent across all products.
o Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows.
o In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

To apply, submit your CV via this advert or contact Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Senior QA Specialist opportunity!

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