QA Scientist for Batch Release

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.

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.

Due to our business expansion and facility growth, we are looking for a QA Scientist for Batch release to join our dynamic team.

As QA Scietntist your responsibilities will include :

• Be involved in the revision of manufacturing batch records and packaging batch records and other batch review documents of pharmaceutical products to be released.
• Participate in the evaluation of deviations, OOS / OOT, complaints, CAPA and Change Controls of pharmaceutical products to be released ensuring the application of GMPs and according to the marketing authorisation or clinical trial authorisation.
• Participate in the certification process of batches susceptible to be released to the market or for clinical trials.
• Review of Quality / Technical Agreements between the company and manufacturers and marketing authorisation holders, especially with regard to batch certification activities.
• Review and approve the documentation involved in the activity of the company : CoA, Site Master File, SOPs, product specifications.
• Collaborate and participate in the revision of audit reports carried out by third-parties to the manufacturers of pharmaceutical products to be released.
• Collaborate in audits carried out by our clients and give support in the Inspections of regulatory authorities.
• Participate in the implementation and improvement of the quality system of the company.

If you join us, you will become part of an agile and growing company with a strong scientific culture.

Here's what you can expect :

Requirements

What we are looking for :

Kymos considers diversity and inclusion as key development priorities, with one of our main goals being to promote a culture that embraces differences and celebrates unique talents. For this reason, we are committed to equal opportunities for all people, regardless of gender, nationality, sexual orientation, gender identity, age, religion or any other personal characteristic.

Sector : Pharmaceutical and biopharmaceutical

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