I am delighted to be working with an exciting Biotechnology company who are focused on driving continuous improvement and innovation within their company to improve the lives of their patients.
This role is an IS Quality Specialist with extensive experience in compliance. It is a permanent position based in Dublin.
The ideal candidate for this role will be a team player who works cross collaboratively internally and externally in order to make effective decisions. They will have a Bachelor's degree in Mechanical/Electrical Engineering or Computer Science. They will have an in-depth knowledge and understanding of GMP environments related to FDA, cGXP and 21 CRF Part 11. A good working knowledge of GAMP software development life cycle would be desirable. Flexibility is key and travel may be required to support various projects and business needs.
Responsible for and leading all IS compliance in relation to processes/procedures, development of SOPs and local plans.
Development of validation plans, IQs, OQs, PQs, and the associated documentation.
Own validation protocols from start to finish in line with GMP and other relevant standards and regulations.
Overseeing NCs, CAPAs, Periodic Reviews and Quality Metrics for the IS team.
Present the IS function for regulatory audits and act as the main point of contact.
Drive continuous improvement throughout for the company.
Deliver IS related training for the site
If this role is of interest to you please click 'Apply Now' or for more information contact Aoife on firstname.lastname@example.org or 021 2300 200.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.