QA Batch Release Trainee

hace 3 días

Barcelona, Barcelona, España Kymos Group A tiempo completo

We are looking for a motivated and detail-oriented Quality Assurance Intern to join our Batch Release team, with a specific focus on the preparation and coordination of Product Quality Reviews (PQRs) in compliance with EU GMP Annex 21 and internal quality procedures.

This internship offers hands-on experience in pharmaceutical quality systems, documentation management, and batch release processes within a highly regulated environment.

Key Responsibilities

  • Support the preparation, review, and compilation of PQRs for commercial products according to EU GMP Annex 21 requirements.
  • Assist in data collection, trending, and evaluation of product quality metrics, deviations, and CAPAs.
  • Support QA Batch Release Scientists and QPs in the batch release documentation review process.
  • Participate in continuous improvement initiatives related to PQR templates, procedures, and data integrity.
  • Ensure compliance with Good Manufacturing Practices (GMP) and company quality standards in all assigned activities.

What We Offer

  • Internship in a dynamic QA environment.
  • Exposure to real-life GMP processes and regulatory compliance activities.
  • Mentorship and training from experienced QA professionals.
  • Opportunity to gain insight into pharmaceutical batch release and product lifecycle management.

Requisitos:

Requirements

  • Degree or Master's degree (completed or in progress) in Pharmacy, Biotechnology, Chemistry, or related field.
  • Basic understanding of EU GMP principles; knowledge of Annex 21 and PQR requirements is a plus.
  • Strong attention to detail, organization, and analytical mindset.
  • Proficiency in Microsoft Excel and Word; experience with quality data systems is an advantage. MiniTab Sofware management is a plus.
  • Good command of English (written and spoken).
  • Team player with willingness to learn and collaborate across functions.

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