Senior Quality Assurance Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeQuality Full time €75,000 - €90,000
Job Title:

Senior Quality Assurance Specialist

Description:

This is a 12-month fixed-term contract with potential for permanency. The Senior Quality Assurance Specialist will play a key role in maintaining the Company's Quality Management System (QMS).

Key Accountabilities/Responsibilities:
  • Support the Quality team in ensuring compliance to ISO and Good Manufacturing Practice (GMP) requirements;
  • Manage the internal QMS, including raising non-conformances, change controls, Corrective Action Preventative Action (CAPA), quality complaints etc.
  • Maintain the supplier management system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures;
  • Ensure compliance to Internal Audit schedules, execute internal audits;
  • Liaise with fellow team members and ensure awareness to changes to QMS as appropriate.
Specific to Role of Responsible Person:
  • Ensure compliance with the requirements of EU Good Distribution Practice (GDP) guidelines and other relevant guidelines including Health Products Regulatory Authority (HPRA) local guidelines;
  • Experience working under MHRA GDP requirements would be an advantage;
  • Ensure the safety, quality and traceability of products are maintained through the entire supply chain;
  • Act as the main point of contact and be legally responsible to the HPRA and advise HPRA of any changes in a timely manner;
  • Lead regular management review meetings with Senior management teams;
  • Coaching/Mentoring Quality professionals/Deputy RPs;
  • Ensure patient safety and product safety at all times.

The ideal candidate will have excellent communication skills, attention to detail and strong analytical abilities. They will also possess a thorough understanding of Quality Management Systems and experience in a similar role.

A competitive salary package and opportunities for career growth and development will be offered to the successful candidate.

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