Senior Quality Assurance Professional

2 days ago

Carlow, Ireland beBeeQuality Full time €40,000 - €60,000
Quality Assurance Specialist

We are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for reviewing and approving manufacturing batch documentation, including electronic batch records and real-time reports.

  • The ideal candidate will have relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment, and knowledge of US and European cGMP guidelines and other international regulatory requirements.
  • You will also provide training in all aspects of Quality Management Systems and GMP, ensuring all work is carried out in line with SOPs, training, or other quality systems.
  • In addition, you will facilitate compliance direction for the site by assisting in adherence to divisional policies and guidelines as well as regulatory requirements.
Key Responsibilities:
  1. Review and approval of all manufacturing batch documentation, including electronic batch records, real-time reports, master data using site systems.
  2. Review and approval of SOPs, cleaning verification/validation data, and other documents as necessary for the IPT department.
  3. Drive effective writing/revising/rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality-related systems; ensure all work is subsequently carried out in line with same.
  4. Support the development and implementation of improved quality reporting measures.
  5. Liaise with Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
  6. Provide effective real-time on-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, aseptic operations.
  7. Provide quality input into decision-making processes on the shop floor, ensuring product quality is maintained.
  8. Ensure all work is carried out in line with SOPs, training, or other quality systems, such as change controls where applicable.
Requirements:
  • Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
  • Knowledge of US and European cGMP guidelines and other international regulatory requirements, as applicable to the site.
  • GMP Audit experience in the pharmaceutical industry.
  • Third-level degree qualified in a Science/Technical or related discipline.

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