Qualified Person

Qualified Person (QP) – Pharmaceutical – Dublin –  Permanent
Minimum 3 years of experience in the pharmaceutical industry required in a Quality role.
Experience as a releasing QP essential.

Fantastic opportunity to join a cell & gene therapy company going through a very exciting growth phase.
For a confidential discussion or a more detailed job description please contact me.

Role Description
This company is seeking to hire a Qualified Person to support its rapidly growing business.

This is an exciting role for a highly motivated individual to join a growing organisation and to be deeply involved in driving Quality Assurance and compliance activities within the company.

You will have the opportunity to work with a variety of clients and industry-leading technologies to support the treatment of patients, including those suffering from rare diseases.

Educational / Professional Details required.

  • Third-level degree in Science or relevant discipline.
  • Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC//536/2014 respectively.
  • Minimum 3 years of experience in the pharmaceutical industry in a Quality role, with experience as a releasing QP.
  • Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs, and ICH guidelines.
  • GMP auditing experience of suppliers in the pharmaceutical industry.
  • Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems.
  • Strong judgment and decision-making skills.
  • Experience in aseptic processing, sterile manufacturing or cell and gene therapy manufacturing is desirable.
  • Direct experience in participation in regulatory audits.
  • Direct experience in the development and oversight of Quality Management Systems.
  • Excellent time management and project management abilities.
  • Excellent written, verbal and interpersonal communication skills and the ability to effectively interact cross-functionally.
  • Ability to handle and prioritise multiple assignments, changing priorities and meet deadlines.
  • Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Some travel is required to support this role e.g., GMP audits. Approximately 10% of time


For further information or a confidential discussion please contact Deirdre Sheehan
086 046 4671

Apply for this job

Job Details

24 July 2023
Job ID: 8509

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