Quality Assurance Leader

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time
Senior Quality Assurance QA Specialist - 12 Month Contract (Full Time)

The Senior Quality Assurance QA Specialist will manage and execute 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.

  1. Reporting to the Quality Manager, this role is responsible 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. This role involves reviewing and approving Standard Operating Procedures and other controlled documents in the PQS. Authors and develops QA SOPs and controlled documents.
  4. A management role with direct QA Specialist reports, focusing on delivering a high-performance quality culture and staff development.
  5. Develops and owns quality metrics for the organization, using data to drive the delivery of quality records on time and foster a high-performance culture.
Responsibilities

This role requires supporting the Quality Manager, QP, and Head of Quality in achieving PQS objectives, including continuous improvement.

  • Advises on master batch documentation development and reviews batch documentation.
  • Liaises with internal stakeholders to ensure compliance with regulations and industry standards.
  • Collaborates with suppliers to ensure quality assurance and compliance.
  • Diligently monitors operational activities at approved service providers.
  • Prepares and reviews Quality Agreements.
Job Requirements

To be successful in this role, applicants should possess:

  • At least 5 years' experience in cGMP pharmaceutical operations with direct experience in quality systems.
  • A primary degree in a scientific discipline or equivalent.
  • An 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.

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