Senior Specialist - Inspection Readiness

Senior Specialist - Inspection Readiness - 10-months+ Contract 

Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a Senior Specialist - Inspection Readiness, to join their team in Dublin for their new large-scale facility. 

This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.  

This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.

Position responsibilities as follows:

• Support the implementation of the Inspection Readiness Program on-site.
• Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
• Lead and perform internal audits (facility, system and walk through) in addition to supporting management of the internal audit schedule at the site.
• Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
• Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.

This role requires a seasoned QA Senior Specialist with a minimum of 8 years’ experience in a similar Compliance-related role in the Biopharmaceutical industry. Must have at least 3 years’ experience in delivering Inspection Readiness Programs and Internal Audit programs in a pharma/biotech regulated environment.  Experience working in a drug substance manufacturing environment is highly desirable.

If this looks like the role for you, please get in touch today!

The candidate must have the rights to work in the location stated in the job advert.

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