QA Specialist

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 QA Specialist 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.

Essential Duties and Responsibilities for this QA Specialist role include, but are not limited to, the following:

• As the QA Specialist you will be responsible fpr supporting the Quality aspects of Qualification and Validation of Drug Substance Production Equipment, Facilities and Utilities.
• The QA Specialist will serve as the Quality SME for all Validation activities across the site which include Upstream, Downstream and Site Systems.
• You will serve as a Quality resource for assessing Validation requirements, Non-Conformance, Impact Assessments, Root Cause Analysis and Implementation of CAPA found during CQV activities.
• You will work alongside the stakeholders and SME’s from Site Operations, Quality Operations, Engineering & MS&T to provide Quality Oversight throughout the Qualification and Validation Lifecycle

• As the QA Specialist you will be qualified to degree level and have a minimum of 3 years’ experience within a QA Specialist position.
• The QA Specialist will have strong experience working in a regulated environment with exposure in the Regulations & Guidance’s GMP, CGMP, GAMP, 21 CFR PART 11
• You will have strong experience in Commissioning, Qualification and Validation activities and a good Technical Knowledge of Cleaning Validation.

If you feel you have the right experience for this position then please apply now!