KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany, as well as a Liaison office in South Korea, 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 to providing high quality and added value services to its partners and 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 200 employees and is committed to promoting diversity, gender equality, well-being, and initiative within its members, encouraging career development and internal promotion.
ResponsibilitiesBe 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 authorization or clinical trial authorization.Participate in the certification process of batches susceptible to be released to the market or for clinical trials.Review Quality/Technical Agreements between the company and manufacturers and marketing authorization 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. RequirementsLife Sciences Degree, preferably with a Pharmacy Degree.2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry.Experience on Biologicals will be highly valued.Knowledge in Pharmaceutical Analysis, Quality Control, Manufacturing, and Quality Assurance following the requirements of Good Manufacturing Practices.A high level of English, both written and spoken, is required for this position. If you join us, you will enjoy working in a dynamic company with a highly qualified growing team, professional development, a collaborative environment, and a culture of empowerment.
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