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Responsible Person – Pharmaceutical Quality & Logistics

H.Essers · Monselice

Junior 🇬🇧 English
EU GDP Guidelines (2013/C 343/01) EU GMP Guidelines (Eudralex Volume 4) EU API GDP Guidelines (2015/C 95/01)

Job description

About the role

We are looking for a Responsible Person to ensure the quality and safety of pharmaceutical products stored and transported by H.Essers. The role combines quality management with logistics, acting as the main contact for regulatory authorities and customers.

Key responsibilities

  • Implement and maintain the quality management system for pharmaceutical products.
  • Manage authorized activities, ensuring accurate and high‑quality records.
  • Develop and maintain the training programme for relevant staff.
  • Coordinate and execute recall operations as requested by customers.
  • Handle customer complaints and oversee qualification of customers, suppliers and subcontracted activities.
  • Run the self‑inspection programme and document any delegated duties.
  • Manage returned, rejected, recalled or falsified medicinal products according to customer decisions.
  • Ensure compliance with national laws and specific Royal Decrees related to narcotics, psychotropic substances and drug precursors.

Required profile

  • Pharmacist or Master’s degree in pharmaceutical sciences, medicine, veterinary sciences, chemistry, biochemistry or biology.
  • 1–2 years experience in distribution, secondary packaging or importation of medicinal products.
  • Strong analytical and problem‑solving abilities.
  • Capacity to work independently and make decisions.
  • Fluent in English and Italian.

Required skills

  • EU GDP Guidelines (2013/C 343/01).
  • EU GMP Guidelines (Eudralex Volume 4).
  • EU API GDP Guidelines (2015/C 95/01).
  • EU GDP Guidelines for Veterinary Medicinal Products (2021/1248).
  • Falsified Medicines Directive (2011/62/EU).
  • Royal Decree of 06 Sep 2017 (narcotics and psychotropic substances).
  • Royal Decree regulating drug precursors (20 Jan 2025).
  • Royal Decree of 12 Apr 1974 (specific hormonal and anti‑infectious substances).

What we offer

  • Competitive salary complemented by attractive benefits.
  • Dynamic and stimulating work environment.
  • Access to H.Essers Academy for free training courses.
  • Support for physical and mental health.

Questions fréquentes

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Published 3 months ago

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H.Essers

Monselice