Requirements: English
Company: IQVIA Italia
Region: Bologna , Emilia-Romagna
Our client, Chiesi Farmaceutici one of the top 50pharmaceutical companies in the world, with more than 80 years ofexperience within the pharmaceutical and biotechnology industry -in order to expand their staff, entrusted to IQVIA the recruitmentof a Analytical Scientist who can join an exciting workingenvironment in a dynamic and international atmosphere. Purpose:Support analytical activities required for producing informationand documentation suitable for preclinical and clinical developmentand registration of drug products, including excipients andintermediates, with particular focus on quality in accordance withGMP/cGMP. Main Responsibilities: - Developing pharmaceuticalproducts (small molecules, new chemical entities, biologicalproducts, excipients, intermediates, Drug Products) in line withQRM principles by designing and evaluating the necessary activitiesboth internal and c/o CRO: - development, validation and transferof analytical methods - stability studies set-up and management -drug products characterization studies - extractables andleachables studies - studies to support formulation andmanufacturing process development (feasibility, refinement,scale-up) - Execute the development strategy of the assignedproject - Contribute to the scientific understanding for theproduct development area - Preparation and revision of technicaldocumentation in line with quality and regulatory requirements andaccording to relevant internal procedures - Writing/reviewing ofregulatory documentation (CTD/NDA, IMPD/IND, Q&A, Briefingdocuments for Scientific advice) - Operate according to the relatedSOPs, cGMPs, safety guidelines and policies as necessary toaccomplish daily tasks. - Support Change Control Evaluation -Support quality investigations (Deviations or OOS, Complaints)Languages: English fluent We offer: - Competitive salary package -Permanent contract - Chemical contract IQVIA reserves the right toevaluate candidates with domicile / residence and work experience /study with requirements responding to the open request.Applications WITHOUT the requirements Will NOT be fully taken intoaccount. Please enter the authorization for the processing ofpersonal data (DL196/2003) - General Data Protection Regulation (13GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAsClients. The research is urgent and is intended for candidates ofboth sexes (L.903/77).