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Senior Quality Specialist

Location: Dublin, Republic of Ireland Salary:
Sector: Quality Assurance (QA) Type: Permanent

Reporting to the Quality Systems & Compliance Manager the Quality System Specialist is responsible for the coordination of key quality activities within the Quality Systems and Compliance group and varying duties as assigned by the Quality Systems and Compliance Manager such as:

  • Provide oversight and management of elements of the Quality Management System (QMS), which include, but not limited to, change control, deviations, CAPAS, Product Complaints, documentation, vendor management and risk management.
  • Develop and write SOP & Controlled Documents.
  • Be a key member of the on site audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Preparation of Key Performance Indicators to align with company and global quality objectives.
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Reviews for all products manufactured on site.
  • Participation in the preparation of documentation for regulatory submissions.
  • To ensure that the systems with a GMP impact are maintained as per written procedures.
  • Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.

Requirements:

Bachelor's degree in chemistry, biology or a related scientific discipline

This role requires a minimum of 5 years working within quality in the pharmaceutical industry.

Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas. Thorough understanding of quality systems and cGMP's.

Bachelor's degree in chemistry, biology or a related scientific discipline

Benefits:

  • Zero Absence Award
  • Health-Care
  • Annual Leave & Privilege Leave
  • Pension Disability & Life Assurance
  • Annual Bonus

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales