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
deirdresheehan@cregg.ie