Senior Quality Assurance QA Specialist - 12 Month Contract

Senior Quality Assurance QA Specialist - 12 Month Contract  About VLE Therapeutics  Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support the GMP manufacturing of clinical and commercial vaccines, next generation biologics & advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients.This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines. To create the best client experience, we will create & implement a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver a Molecule-2-Market accelerator. Stage 1 - At our current APC facility, we are constructing a new state of the art biomanufacturing facility. Operations will employ cutting edge technology including single use equipment & disposables and deploy digital solutions to support the best client experience. Stage 2 - In parallel, we are planning the development of a bespoke 80,000ft2.  greenfield GMP manufacturing facility, which will provide a world-class platform for the manufacture of a wide range of vaccines next generation biologics & advanced therapeutics for our clients globally. Key to enabling our strategy is to create the best culture, the right values & behaviours and as a result, the establishment of a high performing team committed to creating a culture of excellence in everything we do.  Responsibilities for the role Reporting to the Quality Manager, the Senior QA Specialist is responsible for managing and executing QA operational tasks in the PQS, advising and partnering with personnel in Operations, Supply Chain, Quality Control and Engineering to execute VLE tasks compliantly in the PQS, and for identifying and delivering compliant continuous improvement activities QA SME for key PQS systems including deviations, change control, complaints, validation, quality risk management related to manufacturing operations and facility, supply chain, QC, and GxP processes Review and approval of Standard Operating Procedures and other controlled documents in the PQS. Authoring and development of QA SOPs and controlled documents This is a management role with direct QA Specialist reports and with a focus on delivering a High Performance Quality Culture and development of staff Develop and own Quality metrics for the VLE organisation. Use data to drive delivery of Quality records on-time and a high-performance culture Support the Quality Manager, QP and Head of Quality in delivering PQS objectives including continuous improvement of the PQS Responsible for advising and consulting on master batch documentation development and for executed batch documentation review and approval  QA SME for Quality Risk Management activities including leading and, where appropriate, facilitating QRM activities in line with ICH Q9 rev1 Identify and implement continuous quality system improvements and support implementation of improvements in GxP Compliance, Preventive Maintenance, Deviation Management, Change Control Programs and other GxP Systems. Quality Assurance (QA) oversight, on-site manufacturing operations, internal materials management, warehousing operations, and quality control testing activities. Quality Assurance (QA) oversight, of operational activities which occur at approved service providers (QC testing, material storage, material supply, etc.). Preparation and review of Quality Agreements Supplier GxP monitoring during onboarding activities and throughout lifecycle Provide QA and compliance advice and QA direction to projects impacting manufacturing activities. Contribute to and execute assigned inspection readiness activities, regulatory inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions. Development of VLE’s QA capabilities and services which will underpin VLE’s delivery of services to clients supporting delivery of commercial revenue e.g. supplier quality management Responsible for establishing and maintaining processes to support the QP team in relation to preparation, review and communication of quality records in addition to relevant documentation for release activities. Job Requirements At least 5 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systems Primary Degree in scientific discipline or equivalent Demonstrated ability to work flexibly and independently to influence a high-performance Quality culture Excellent decision-making skills in particular as relates to making decisions in a nuanced framework Experience in managing and developing staff an advantage Experience in one or more of the following an advantage : Supplier Quality Management activities Quality Risk Management experience, in particular experience in leading or facilitating QRM activities Good Distribution Practice How to apply : Suitable applicants should submit a CV and Cover Letter. Please note that the closing date for applications for this position is  31st May 2025   VLE is committed to the principle of equal opportunity for all employees.  All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and / or expression, marital status, or any other status protected by Irish law.   Salary Negotiable   VLE is committed to the principle of equal opportunity for all employees.  All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and / or expression, marital status, or any other status protected by Irish law.   Salary Negotiable