Qualified Person

We are recruiting a Qualified Person to join a leading biopharmaceutical company based in the County Waterford area. This role offers the chance to work within a global company committed to transforming medicine and improving patient outcomes. You will be integral to ensuring the safe and compliant release of pharmaceutical products, supporting a dynamic pipeline of innovative therapies.

This is an initial 12 month contract with possible extension. We are only able to consider candidates available to contract 5 days per week, hybrid working can be offered.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:

• As the QP. you will manage the batch disposition process to ensure the timely and compliant release of licensed products.
• As the QP. you will ensure that all batch releases adhere to site standards, regulatory requirements, and EU directives.
• As the QP. you will support and oversee investigation processes, ensuring all deviations are closed prior to product release.
• As the QP. you will participate as the Quality/Qualified Person representative on cross-functional teams and provide quality support across departments.
• As the Qualified Person, you will maintain independence in decision-making regarding quality issues and uphold industry best practices.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Qualified Person we are looking to identify the following on your profile and past history:

• A Degreed or higher in a relevant science or pharmaceutical discipline (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
• Proven experience of at least 8 years working within a cGMP environment, with relevant experience acting as a Qualified Person for licensed products.
• Extensive knowledge of sterile manufacturing processes, biologics, and clinical trial regulations is highly desirable.

Key Words: qualified person / biopharmaceutical / quality assurance / GMP / regulatory compliance / sterile manufacturing / clinical trials / leadership / career development / hybrid working / steriles / aseptic / EMA / HPRA / MIA / Biologics / Biologicals / Pharma / Pharmaceutical

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."