Ofertas de empleo en Cerdanyola del Vallès de Informática y telecomunicaciones

Kymos is hiring a Scientist in Chemical Analysis for our Quality Control department:

Position Description:

• We offer a position in the Pharmaceutical Chemical Analysis Department as a Scientist responsible for the analysis of active ingredients and pharmaceutical specialties.
• The role involves designing, supervising, and conducting studies on the development and validation of analytical methods for drug control, stability studies, quality control, etc. Analytical techniques employed include HPLC, GC, potentiometry, Karl Fisher, UV, dissolution testing, etc.
• The work is conducted in compliance with GLP and GMP regulations.

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 ensuring 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 ensuring 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.

Buscamos a analistas para nuestro departamento de Control de Calidad, donde se analizan principalmente materias primas, producto acabado y especialidades farmacéuticas.

Las responsabilidades son:

• Dar soporte a los químicos analíticos en la preparación de muestras y en el uso de diversas técnicas analíticas (potenciometrías, Karl Fisher, Cromatografia Líquida de Alta Resolución (HPLC), cromatografía de gases, UV, Test de disolución, etc)
• Realizar el trabajo en un entorno de cumplimiento de Buenas Prácticas de Laboratorio y GMP

We are looking for analysts for our Quality Control Department, where we analyze mainly raw materials, finished products and pharmaceutical specialties.

The responsibilities of the position are:

• Support analytical chemists in the preparation of samples and the use of various analytical techniques (potentiometries, Karl Fisher, high performance liquid chromatography (HPLC), gas chromatography, UV, dissolution test, etc)
• Perform the work in an environment of compliance with Good Laboratory Practices and GMP.

We are hiring a Quality Assurance Scientist for our GMP area of Quality Assurance Department.

The QA Scientist will be assigned the following responsibilities:

• Review and approve the documentation involved in the analytical activity of the company: CoA, protocols, reports, SOPs, product specifications.
• Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to cGMP regulations.
• Participate in the QA Annual Program of self-inspections.
• Verify the conformity of quality controls established in the company’s processes.
• Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
• Review of the 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.

The QA Scientist will be assigned the following responsibilities:

• 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 trail 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 authorisatio 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.