The role: PE Global is currently recruiting for a QC Lab Instrumentation Specialist on behalf of a leading biotech company based in Dublin North. This is an initial 11-month contract role. Description: The role of Quality Control (QC) Instrumentation Systems Specialist operates as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab. The team working style is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation. Our Quality Control group ensures all materials used for our products is manufactured, processed, tested, stored, and distributed aligned with our incredibly high standards of quality, meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Responsibilities: Responsible the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation. Support the QC department for troubleshooting, investigations, and deviations as an SME. Manage deviations, CAPAs and change controls related to the QC and team priorities. Assist with implementation of Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes. Author and revise local SOPs, work instructions, and guidelines. Serve as an SME for regulatory and internal inspections and audits. Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop. Education and Experience: A bachelors degree in Engineering, biological science, or related field. 3 years experience in CSV and/or CQV for laboratory systems and instrumentation Experience in regulatory audits. Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP). Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: quality control lab systems instrumentation
