QA - Change Control

Pe Global

Cork

PE Global are currently recruiting for a Change Control Specialist for a client site in Cork: Job Description Provide change control support for the manufacture and testing of clinical and commercial biologics, vaccines and small molecules Drug substance and Drug products (cross modality. Reports to Associate Director QA Change Control. Change Control activities include: Position will involve assessing, reviewing and progressing change control documentation from all areas on site as part of a cross-functional team. Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision while ensuring communication to area leadership. When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, while considering operational impact to the site. Review change control documentation for clarity, ensuring relevant supportive data has/ will be generated. Confirm categorisation of change in accordance with site and Global procedures. Establish productive working relationships with colleagues within own and project teams at site and with other colleagues in the network. Collaborate with site Change Owners, SMEs, and CMC to determine impact to Clinical / commercial licenses for proposed changes. Provide Change control support as required during HA inspections. Provide change control training to the site in accordance with procedures. Share best practice with the team and the network. Carry out annual product reviews from Change Control Perspective. Any other tasks as deemed necessary to support the change control function. Qualifications Degree in biochemical/ biomechanical engineering or equivalent. Advanced degree preferred. Experience Min 3-5 Years operations experience -Regulatory / Technical / QA experience in a manufacturing operations environment and/or support function or equivalent. Equipment / validation / C&Q / software engineering experience desirable. Project management skills. Interested candidates should send their CV to audrey.mccarthy@peglobal.net or call 0214297900. 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.

1914 days ago