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

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

Role Requirements

• 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.

HRS is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.