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Lead Quality Assurance Consultant - United Kingdom & Ireland
Blackfield Associates are partnered with a leading biologics and advanced therapeutics CDMO in the search for a Senior Quality Assurance Specialist to join their growing team on a 1-year fixed term contract, based in Dublin, Ireland.
As the Senior QA Specialist, you will be responsible for overseeing QA operational activities within the Pharmaceutical Quality System, providing expert QA guidance to operational teams, and supporting continuous improvement initiatives to maintain high standards of GMP compliance.
Key responsibilities within the position will include (but are not limited to):
* Acting as QA SME for key PQS systems including deviations, change control, complaints, and quality risk management.
* Providing quality oversight for manufacturing operations, material management, warehousing, and QC testing activities.
* Leading and facilitating Quality Risk Management activities in accordance with regulatory expectations.
* Managing and reviewing controlled documentation including SOPs and batch records, and supporting batch release activities.
* Supporting inspection readiness activities and contributing to client and regulatory inspections.
The ideal candidate will have a minimum of 5 years’ experience in cGMP pharmaceutical operations including direct involvement with Quality Systems, along with a primary degree in a scientific discipline (or equivalent). Experience managing staff, as well as exposure to Supplier Quality Management, Quality Risk Management, and Good Distribution Practice, would be advantageous.
If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Biotechnology Research and Pharmaceutical Manufacturing
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