QA Compliance Specialist – REF 01889EW

QA Compliance Specialist 

We are actively seeking to recruit a Compliance Specialist for our client, a global biopharmaceutical manufacturer based in Dublin.  The successful candidate will support GMP and inspection readiness activities and as required collaborate with the Internal Audit team. 


Provide Quality and cGMP input and oversight for GMP readiness activities
Review and approval of pre executed and post executed protocols
Review of technical support documentation
Review of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
Provide support for internal audit and inspection readiness activities 


Degree in natural or applied sciences (Pharmacy, Biology, Biotechnology, Engineering)
Minimum 5 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role
Experience in startup facilities a distinct advantage
Demonstrated problem solving capabilities
Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
Experience in Trackwise and SAP an advantage 


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