Qualified Person (Qp)

Descripción del empleo 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. 0 años Requisitos mínimos Requisitos mínimos: 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.