Pharmaceutical Development Specialist

Há 6 dias


Porto, Porto, Portugal Phiture Tempo inteiro

Job Overview

The role of Pharmaceutical Development Specialist involves performing analytical and documentation activities essential for the development and validation of analytical methods, cleaning procedures, and manufacturing processes.

This position will focus on drug substances and finished drug products at various stages of their lifecycle, including new chemical entities, clinical trial materials, and commercial products.

The Key Responsibilities

  • Perform physical and chemical tests under the scope of Development and Validation activities;
  • Support manufacturing activities of Clinical Trial Materials and Commercial Products;
  • Prepare technical documentation to support Regulatory and Validation activities;
  • Actively contribute to the Quality Management System (change controls, deviation, OOS/T/E, complaints);
  • Adhere to and enhance compliance with GMP, regulatory, and legal requirements;
  • Contribute to equipment and infrastructure qualification.

Requirements

To be successful in this role, you will need:

  • Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or equivalent;
  • 5 years of experience in similar roles in the Pharmaceutical Industry (preferably);
  • cGMP and analytical instrumental analysis relevant experience;
  • Updated knowledge and experience of technical guidelines, regulatory and legal requirements under the scope of pharmaceutical development and validation activities;
  • Team player; Curious, dedicated and enthusiastic;
  • Strong computer and digital skills;
  • Fluency in written and spoken English.


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