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Qualified Person (QP)

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

I am working in close partnership with the company to find their next Qualified Person to work on one of the start-up sites in Dublin. The Quality Person/Quality Assurance Executive is responsible for managing the Quality Assurance team associated with production of oral solid dosage product. The QP will assume the role of Lead Qualified Person for the release of the product in accordance with EU Directive 2001/83/EC.

RESPONSIBILITIES:

  • Implementing efficiency improvements in Quality Dept. on a continuous basis and participating in site projects and initiatives.
  • Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
  • Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
  • Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Management of batch disposition and material status control activities associated with the product acting as a site Qualified Person.

EXPERIENCE REQUIRED:

  • Primary Degree in a scientific discipline
  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.
  • Minimum of 5 year's experience in the pharmaceutical industry in a Quality role.
  • Minimum of 2 year's experience working as a Qualified Person.
  • Experience of oral solid dosage manufacture.

For immediate consideration apply with an up to date CV.

No CV ready? Not sure yet? Please get in touch for more info.

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