QA Associate - Cork

Pe Global

Cork

PE Global is currently recruiting for a QA Associate for Biopharma client in Cork for a 23 month initial contract - Duties: Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives. Review and Approval of electronic and paper production batch record. Daily presence and support on the manufacturing floor. Release of Raw Materials for production. Support the Technology Transfer of a new product into the site including raw material and supplier qualification. Support quality systems on site. Review and approve new or updates to standard operating procedures (SOPs) and master batch records. Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented. Review and approve Change Control documents. Assist with regulatory inspections. Support the following activities, as appropriate: Document Control, New or updates to relevant quality agreements, Process and Cleaning Validation activities, Continuous Improvement/Lean initiatives. Compile and present metrics. Other duties as assigned. Skills: Minimum 3 years’ relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance. Experience and ability to work cross functionally. Experience in supporting manufacturing operations and batch record review is highly desirable. Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations. Education: Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required. Interested candidates should submit an updated CV, marked for the attention of Audrey. audrey.brennan@peglobal.net or 00353 21 4297900. 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. This job originally appeared on RecruitIreland.com.

1916 days ago