QP – Clonmel

The Operational Quality Manager/QP will act in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of  products. The Operational Quality Manager/QP plays a key role on site and will sit on the Quality Leadership Team. 


  • Manages the batch disposition process to ensure timely release of products.
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
  • Disposition of  products and materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
  • Support major investigations, ensuring all product deviations are closed prior to batch release.
  • Reviews and approves Product Quality Reviews.
  • Reviews and approves new and revised master manufacturing records.
  • Participates in cross-functional teams as Quality/Qualified Person representative.
  • Participate in third party/supplier audits, as required.
  • Review annual customer complaints.
  • Participation in any product recall or product defects.
  • Actively contribute to continuous improvement initiatives.
  • Conduct duties in a safe manner and report all safety issues and concerns.
  • Complete all duties as per relevant SOP’s.
  • Review of investigation reports.
  • Review of validation protocols.
  • Review of Quality Documentation as appropriate e.g. Bill of Materials etc.
  • Work with relevant departments to ensure timely closure of Quality Actions / Findings.
  • Provide additional QP support to quality related issues, as required


  • Must meet the minimum training/education requirements for QP qualification
  • Must have at least 5-7 years’ experience working within a Quality Assurance role
  • Work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable. 
  • Finished dosage formulation manufacturing experience is a requirement for the role
  • Outstanding organisational and time-management skills.
  • Ability to leverage/collaborate effectively with internal and external stakeholders
  • Excellent written and verbal communication and interpersonal skills.
  • Strong problem-solver.
  • Resourceful.
  • Independent, critical thinker with strong decision-making skills.
  • Comfortable working in a busy, fast paced regulated manufacturing environment.

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