Qualified Person

Hyper Recruitment Solutions Ltd

Waterford

Hybrid

EUR 110,000 - 138,000

Full time

6 days ago
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Benefits offered by this job

Hybrid working 2 days remote

Job summary

Hyper Recruitment Solutions Ltd is seeking a Qualified Person to join a leading biopharmaceutical company in Waterford, Ireland. You will manage batch disposition, ensure releases meet regulatory standards, and support deviations and investigations.

This is a 12-month contract with a hybrid setup offering 2 days remote per week. Applicants should hold a degree in a relevant science and have extensive cGMP experience as a Qualified Person.

Qualifications

  • Degreed or higher in a relevant science or pharmaceutical discipline.
  • Proven experience of at least 8 years in a cGMP environment with Qualified Person responsibilities.
  • Knowledge of sterile manufacturing, biologics, and clinical trial regulations is desirable.

Responsibilities

  • Manage batch disposition to ensure timely, compliant release of licensed products.
  • Ensure all batch releases align with site standards, regulatory requirements and EU directives.
  • Support and oversee investigations, ensuring deviations are closed prior to product release.
  • Participate as Quality/Qualified Person on cross-functional teams and provide quality support.
  • Maintain independence in decision-making regarding quality issues.

Skills

GMP experience
Quality assurance
Regulatory compliance
Leadership
Biopharma

Education

Science/pharmaceutical degree

Job description

# Qualified Person*16034**Contract*€80 - €100 Per HourSite BasedWaterford, Ireland Updated on: 16-10-2026Apply NowWe are recruiting aQualified 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. 2 days per week remote 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.\"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.#### Your Recruitment Consultant##### Fabio RoqueRecruitment Manager
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