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Pharmaceutical Quality Assurance Specialist

3 weeks ago


Dublin, Dublin City, Ireland beBee Careers Full time
Quality Assurance Lead Role

This position involves leading and managing QA operational tasks in the Pharmaceutical Quality System (PQS), ensuring compliance with regulations and industry standards.

  1. As a key member of the quality team, this role is responsible for developing and implementing quality assurance strategies.
  2. Serves as a Subject Matter Expert (SME) for key PQS systems, including deviations, change control, complaints, validation, quality risk management, and GxP processes.
  3. This role requires reviewing and approving Standard Operating Procedures and other controlled documents in the PQS.
  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, driving data-driven decision making.
Responsibilities

This role involves collaborating with internal stakeholders to ensure compliance with regulations and industry standards.

  • Reviews and advises on master batch documentation development and reviews batch documentation.
  • Collaborates with suppliers to ensure quality assurance and compliance.
  • Monitors operational activities at approved service providers.
  • Prepares and reviews Quality Agreements.
Qualifications

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.
  • Ability to work independently and influence a high-performance quality culture.
  • Strong decision-making skills in nuanced frameworks.