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QA Batch Release Trainee
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Kymos Group
KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain (Cerdanyola del Vallés- Barcelona), Italy (Monsano-Ancona), and Germany (Frankfurt) and a Liasson office in South Korea (Seoul), offering comprehensive bioanalytical and CMC analytical services to the life sciences industry. Its laboratories are GMP and GLP certified and GCP compliant, and have been successfully inspected by EMA, FDA, and ANVISA.
KYMOS GROUP is devoted in providing high quality and added value services to its partners and it is highly oriented to innovation, offering services of research, development and quality control in many different fields such as small molecules, proteins, antibodies, nucleic acids, and advanced therapies.
KYMOS GROUP has a young and dynamic staff of more than 250 employees, and it is committed in promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.
Descripción de la oferta
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.
