QA SCIENTIST FOR BATCH RELEASE
Descripción de la oferta de empleo
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.
Detalles de la oferta
- Kymos S.L.
- 07/11/2024
- 05/02/2025
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