Hartley People

Qualified Person – Hybrid

  • Full Time
  • Munster

Hartley People Recruitment a seeking a Qualified Person to join our clients pharmaceutical, manufacturing and distribution consultancy company based in the South East.

All levels of experience welcome to apply!

Key Responsibilities:

  • Act as site contract QP to be responsible of manufacturing release of medicinal product and participant in GMP production activities
  • To act as a QP and Batch Release
  • Certify medicinal product in accordance with requirements of product marketing authorization, EU Directive 2001/83/EC & 2001/20/EC and EU GMP Annex 16
  • Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented
  • Coordinating sampling activities for incoming materials
  • Work with functional department to create department SOPs and assure compliance with EU/FDA GMP regulations

Key Requirements:

  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC and have strong QA experience
  • Experience working as a QP desirable
  • BSc Degree in related discipline along with MSc or Post grad which leads to QP status
  • Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC)
  • Experience of Quality systems to include but not limited to deviation, out of specs, risk management
  • Full clean driving licence and own vehicle

For immediate consideration please email your CV to Rachel@hartleypeople.com in response to this job posting.

Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence, and we guarantee that your CV will not be sent to any of our clients without your prior consent.

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