QA Validation Specialist

The role: PE Global is currently recruiting for a QA Validation Specialist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role. Description: Carlow is offering an amazing opportunity for a Quality Assurance Specialist to join our quality team. In this role, you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation completed at our Carlow facility. As the QA Specialist for Validation and New Product Introduction (NPI), you will be an essential member of our esteemed Technical Transfer/Validation Team. This team holds responsibility for managing the development and manufacture of vaccines and biological products. Alongside your day-to-day QA activities, your main focuses will be reviewing and approving all Validation documents relating to a sterile facility including cleaning validation ensuring to support corporate compliance and regulatory expectations for manufacturing. You will report to the Associate Director of Quality and collaborate closely with cross-functional teams on-site, particularly Technical Engineering. Your key objective will be to ensure that manufacturing, technical, and regulatory requirements are met. Responsibilities: Provide quality oversight and direction for the introduction of new products. Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings. Participate as a functional expert in the cross-functional team responsible for introducing products at Carlow. Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation. Review documentation associated with new product, such as, QC Test Specifications, BOMs, and MES documentation. Support deviation close out in a timely manner. Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups. Education and Experience: A Bachelor's degree or higher in a related Science discipline is preferred. A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices. Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred. Strong report, standards, and policy writing skills. Experience with equipment and process validation. Familiarity with sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computer applications. Experience or familiarity with Lean Six Sigma methodology is desired. Good collaboration skills and the ability to work effectively as part of a team to determine priorities. Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance. Proven ability to drive the completion of tasks. Strong decision-making capability with a sense of accountability and responsibility. Demonstrated problem-solving skills. 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 assurance validation qualification commissioning GMP aseptic