PE Global are currently recruiting for a SR QA Tech Support role to be based in our Bio client site in South Dublin on a 12 month initial contract: Hybrid 3 days on site per week Quality Assurance Specialist Senior Technical QA Position Summary: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new syringe and inspection lines and products at our facility in Dun Laoghaire. This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation and Technical Transfer requirements. The desired candidate should have a proven track record in QA leadership, and be comfortable working as part of a cross functional team. Key Responsibilities: Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards. Lead Quality review and approval of validation documentation associated with new facilities and new product introduction Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable. Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements. Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations. Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas. Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction. Provide input and Quality Oversight for change control development and implementation. Ensure timely and robust implementation of change controls and CAPA records. Write, review, and approve Standard Operating Procedures (SOPs) in alignment with policies. Ensure all activities align with safety standards, SOPs, and regulatory expectations. Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations. Preferred Qualifications: University degree in a Science-related discipline. Minimum of 7 years relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing) In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections. Experience working in aseptic operations, relating to vial and syringe filling. Understanding of principles of Validation and New Product Introduction Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions) Strong organizational skills with the ability to manage tasks through to completion. Ability to work independently and remotely with minimum direct supervision. Strong critical thinking and problem-solving abilities Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. To apply, please call Audrey 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: validation qa specialist change control