KYMOS GROUP is a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany and a Liasson 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 it is committed to promoting diversity, gender-equality, well-being, and initiative within its members, encouraging career development and internal promotion.
We are hiring a Qualified Person (QP) for our Quality Assurance Department The Qualified Person (QP) will be assigned the following responsibilities: Review and approve the documentation involved in the analytical activity of the company: CoA, Site Master File, SOPs, product specifications.
Participate and be involved in the revision of manufacturing batch records and packaging batch records and other batch review documents of products to be released.
Participate in the certification of batches susceptible to be released to the market (QP release) and ensure the application of the GMP according to the marketing authorization of the finished drug product.
Participate in the certification of investigational medicinal product batches susceptible to be released for a clinical trial and ensure the application of the GMP according to the investigational medicinal product Dossier.
Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
Review of the review of Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
Collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the Inspections of regulatory authorities.
Participate in the implementation and improvement of the quality of the company and subcontractors.
Requirements We are looking for a candidate experienced as Qualified Person or deputy QP or a candidate with a Pharmacy Degree and with 2 years of experience in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry.
Experience on Biologicals will be highly valued.
The candidate should have 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.
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