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!