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QP

Job Seekers Ireland Science Life Science

Job Summary

  • Dublin
  • Contract
  • BBBH811319
  • Mar 29, 2022
  • Competitive
Job Description

Sligo and Dublin are both on a search of Qualified Person (QP ) to join their pharmaceutical team on a 12 month contract

Job Purpose:

Act as a Qualified Person in accordance with EU Directive 2001/83/EC. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organisational, supervisory, technical writing and investigation skills are required.

Key Responsibilities:

  • To act as the QP for one of the production plants.
  • Direct contact with relevant production Coordinator on GMP issues.
  • Cooperation with Production to ensure continuous improvement
  • Provide details on corrective actions required for batch deviations
  • Assist in the implementation of Quality Systems within production to ensure compliance with GMP
  • Provide regular feedback to other QP's on main issues for relevant production plant
  • To act as QA representative on major projects as required.
  • Communication / liaison with other departments.
  • Participate fully in any cross-functional training initiatives.
  • Participate in the vendor audit program.
  • Participate in the self-inspection programme.
  • To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required.
  • Maintenance of the Quality Systems

Educational and Additional Requirements:

  • Have a minimum of five years' experience in the Pharmaceutical Industry in a QA role.
  • QP experience in API or SOD manufacture and/or packaging is preferable.
  • Good organizational, investigational & technical writing skills are required

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Ula Niwinska
Ula Niwinska
  • Consultant | Science Recruitment
  • 353 (0) 21 2300300
  • uniwinska@morganmckinley.com