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Senior QA Validation Specialist
2 weeks ago
Description: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: 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 at our facility. This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation 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: Quality Oversight of new equipment qualification: 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 c & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards. Validation and Documentation: Quality review and approval of validation documentation, including: Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES). Validation Plans, Protocols (IQ, OQ, PQ), and associated reports. Ensure robust and compliant validation documentation to support site activities. Risk Management and Compliance: Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction. Provide input and quality oversight for change control development and implementation. Ensure timely and robust implementation of change controls and CAPA records. Documentation and SOPs: Write, review, and approve Standard Operating Procedures (SOPs) in alignment with Amgen policies. Regulatory and Safety Compliance: Ensure all activities align with Amgens safety standards, SOPs, and regulatory expectations. Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations. Education and Experience: University degree in a Science or Engineering-related discipline. Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry. Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management. Strong understanding of validation principles and regulatory requirements for C & Q / Validation (FDA, EMA guidelines). Experience with change control, non-conformance resolution, and CAPA implementation. Excellent organizational, communication, and collaboration skills. Ability to work independently with minimal supervision and operate effectively across functional boundaries. Critical thinking and problem-solving abilities. 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 GMP compliance FDA
