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QUALITY ASSURANCE SCIENTIST (FOCUSING ON BATCH RELEASE)

Descripción de la oferta de empleo

Quality Assurance Scientist DNA Life Sciences is currently working with a medium-size and fast-growing Contract Research Organization (CRO) with headquarters in Spain and laboratories in Spain, Italy, and Germany, 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.The organization 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.Job descriptionThe 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 authorization or clinical trial authorization.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 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 clients and give support in the Inspections of regulatory authorities.Participate in the implementation and improvement of the quality system of the company.RequirementsWe are looking for a candidate with a Life Sciences Degree, preferably with a Pharmacy Degree, and with 2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. Experience with 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.Please reach out to shaun@dnalifesciences.co.uk If you have any questions
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Detalles de la oferta

Empresa
  • DNA Life Sciences
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 03/04/2025
Fecha de expiración
  • 02/07/2025
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