10 nov
|
Kymos Group
|
Barcelona
10 nov
Kymos Group
Barcelona
Working in a CRO means ensuring that every pharmaceutical product meets the highest quality standards before reaching patients or clinical studies.
At Kymos Group, we are looking for a QA Scientist to join our QA Batch Release team. As a Scientist, you will play a key role in the batch certification and release process, ensuring that pharmaceutical products comply with GMP requirements, regulatory expectations, and quality standards. You will work closely with manufacturers, clients, and internal teams while contributing to a robust quality culture within a highly regulated environment.
You will become part of a CRO specialized in analytical services for the pharmaceutical and biotechnology industries, where you will gain exposure to a wide range of pharmaceutical products, quality systems, and regulatory requirements while supporting activities critical to product release and patient safety.
The challenges you will take on:
- Review batch records, packaging records, and related documentation prior to product release.
- Support batch certification and release activities for commercial and clinical products.
- Participate in investigations of deviations, OOS, OOT results, complaints, CAPAs, and Change Controls, ensuring GMP compliance.
- Review and approve quality documentation, including CoAs, SOPs, Site Master Files, and product specifications.
- Review Quality and Technical Agreements and support audits and regulatory inspections.
- Contribute to the continuous improvement of the Quality Management System (QMS).
Requisitos To move forward together, you will need:
- Bachelor's degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related scientific discipline.
- Minimum 2 years of experience in Quality Assurance, Quality Control,
or Manufacturing within the pharmaceutical industry.
- Experience in batch certification and batch release activities.
- Knowledge of GMP requirements, pharmaceutical quality systems, and quality processes including deviations, CAPAs, Change Controls, OOS, and OOT investigations.
- Experience reviewing technical and quality documentation with high attention to detail.
- Advanced level of English, both written and spoken.
We will particularly value Experience working with biological products, biosimilars, monoclonal antibodies, or other biopharmaceutical products. What will you find at Kymos?
- Permanent contract.
- Annual training plan and growth opportunities within an expanding company.
- Flexibility in start and finish times, as well as in planning your vacations.
- Adaptable compensation plan: private health insurance, transportation, or meal benefits.
- - Additional compensation for the afternoon shift.
- Fruit and nuts available to enjoy two days per week.
Our headquarters are located in Cerdanyola del Vallès, in a green setting at the foothills of Collserola, featuring a rooftop terrace and convenient parking facilities. Apply now and help advance your potential with Kymos!
Get to Know Kymos
Discover who we are, what we do, and the science that drives our projects.
https://www.youtube.com/watch?v=DdhXQimMS20
At Kymos, we consider diversity and inclusion key priorities for our development. One of our main objectives is to promote a culture that values differences and recognizes the unique talent of every individual. Therefore, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion, or any other personal characteristic.
📌 QA Scientist for Batch Release (Barcelona)
🏢 Kymos Group
📍 Barcelona