Quality Assurance Officer

2 semanas atrás

Coimbra, Portugal Laboratórios Basi - Indústria Farmacêutica Tempo inteiro

Quality Assurance Officer (Process Validation) Laboratórios BASI – Industria Farmacêutica S.A., in Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Quality team:QUALITY ASSURANCE OFFICERMISSION:Performing validations of manufacturing and cleaning processes foreseen in the validation plan, respecting validation protocols, internal requirements, legislation and Good Manufacturing Practices.Main responsabilities:- Collaborating in the development and execution of validation programs for cleaning, manufacturing, filling, packaging and Hold Time processes;- Preparing procedures, listings, models, protocols for the validation of manufacturing and cleaning processes;- Elaborating process validation and cleaning validation reports, Criticality Analysis reports and analysis reduction reports and analysis reduction reports on the intermediate product;- Characterizing new processes through Critical Process Attributes (Critical Process Attributes);- Monitoring the status of existing manufacturing processes under periodic guidance from a qualified colleague.- Monitoring routine process (field) validation and monitoring processes.- Performing analysis of the documentation of batches manufactured in the last year for each product;- Supporting the preparation of Product Quality Review (PQR) reports and Q3D reports;- Collaborating in the product research process and in the implementation of their corrective actions / improvement action plan.Profile:- Graduation or Master Degree in a relevant area to the function- Fluent English (spoken and written)- Experience in the Pharmaceutical Industry (preferential)- Knowledge of GMP- Experience in Quality Assurance#J-18808-Ljbffr

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