Global R&D Qa, Senior Gmp Product Compliance Specialist

5 giorni fa

Parma, Italia Chiesi Group A tempo pieno

Who we are looking for Purpose Guarantee the compliance with EU and US regulations related to the application of the Good Manufacturing Practices for biological products for clinical trials.Main Responsibilities QA GMP reference in Project Teams related to Biological Products for clinical trials Review of Master Batch Record related to biotechnological Drug Substance, Drug Product and Advanced Therapy medicinal Products Management of change, OOS, deviation, Temperature excursions Review of GMP protocol and report (Technology transfer, Process validation, etc.) Clinical Trials Supplies complaint management Quality Agreement review for the relevant sections in relation to the projects assigned Drafting, revision and harmonization of Standard Operating Procedure Training execution on the Standard Operating Procedure QA site compliance (Sweden laboratories) Experience Required Experience in Quality Assurance, Quality Control or production in Biotech/Biopharmaceutical companies of at least 5 years.Education Degree in Biology or Biotechnology, Chemistry and Pharmaceutical Technology, Pharmacy.Languages Proficient in spoken and written English.Technical Skills Knowledge of the EU-GMP, CFR 21 part ******* and 600, ICH in the field of pharmaceutical development Knowledge of the process of drug development Knowledge of drug product manufacturing processes, in particular sterile/aseptic/lyophilization processes applied to biological products Knowledge of drug substance manufacturing processes, in particular recombinant proteins, monoclonal antibodies Knowledge of analytical/bioanalytical technique Knowledge of ERP and EDMS Knowledge of training technique Soft Skills Planning and organization skills Team working Decision making ability Independence in judgment and objectiveness Location Parma, IT.Availability is requested to spend 25% of the time at the R D site in Sweden.What we offer You would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development.Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best.That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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