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Qualified Person

  • Sector: Science & Pharma
  • Contact Email:
  • Job Ref: 21134

We are partnering with a leading pharma organization in Tipperary, who is looking to hire a Qualified Person.

QP is pivotal within the site and involves being a member of the Quality Leadership Team.

In this role, you will review and approve product quality before it's released into the market, and manage the batch disposition process.

Overview of Main Responsibilities (full job description available on request):

  • Maintain compliance with site practices and regulatory requisites in the batch disposition process.

  • Execute the 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.

  • Assist in significant investigations, ensuring resolution of all product deviations before batch approval.

  • Assess and grant approval for Product Quality Reviews.

  • Evaluate and authorize new and revised master manufacturing records.

  • Represent Quality/Qualified Person in cross-functional teams.

  • Take part in audits of third-party suppliers as needed.

  • Contribute in situations involving product recalls or defects.

  • Actively engage in initiatives for continuous improvement.

  • Review investigation reports and validation protocols.

  • Provide additional support as a Qualified Person for quality-related matters as necessary.

What the ideal Qualified Person looks like:

  • 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

  • Excellent written and verbal communication and interpersonal skills.

  • Comfortable working in a busy, fast paced regulated manufacturing environment.

For a confidential discussion and more information on the role, please contact Alicja Burchardt.

(021) 2427109