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Senior Quality Assurance QA Specialist

4 weeks ago


Dublin, Dublin City, Ireland APC Ltd Full time
Senior Quality Assurance QA Specialist - 12 Month Contract (Full Time)Dublin, IrelandDescription

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.

Responsibilities for the role
  1. 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.
  2. Serve as 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.
  3. Review and approve Standard Operating Procedures and other controlled documents in the PQS. Author and develop QA SOPs and controlled documents.
  4. This is a management role with direct QA Specialist reports, focusing on delivering a high-performance quality culture and staff development.
  5. Develop and own quality metrics for the organization. Use data to drive the delivery of quality records on time and foster a high-performance culture.
  6. Support the Quality Manager, QP, and Head of Quality in achieving PQS objectives, including continuous improvement.
  7. Advise on master batch documentation development and review and approve batch documentation.
  8. Lead and facilitate Quality Risk Management activities in line with ICH Q9 rev1.
  9. Identify and implement improvements in GxP compliance systems, including deviations, change control, preventive maintenance, etc.
  10. Oversee QA activities in manufacturing operations, internal materials management, warehousing, and quality control testing.
  11. Monitor operational activities at approved service providers.
  12. Prepare and review Quality Agreements.
  13. Conduct supplier GxP monitoring during onboarding and throughout the lifecycle.
  14. Provide QA and compliance advice for manufacturing projects.
  15. Participate in inspection readiness activities, regulatory inspections, and follow-up actions.
  16. Develop VLE's QA capabilities, including supplier quality management.
  17. Establish processes supporting the QP team for quality record review and communication.
Job Requirements
  • At least 5 years' experience in cGMP pharmaceutical operations with direct experience in quality systems.
  • Primary Degree in a scientific discipline or equivalent.
  • Ability to work independently and influence a high-performance quality culture.
  • Strong decision-making skills in nuanced frameworks.
  • Experience in staff management and development is advantageous.
  • Experience in supplier quality management, quality risk management, or good distribution practice is advantageous.
How to apply:

Applicants should submit a CV and Cover Letter. The closing date is 31st May 2025.

VLE is committed to equal opportunity employment and bases employment decisions on business needs, job requirements, and individual qualifications, regardless of gender, ethnicity, age, religion, disability, sexual orientation, gender identity, or marital status.

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