Ph3Overview /h3pOur client Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, is expanding its staff. IQVIA is recruiting an Analytical Scientist to join an exciting working environment in a dynamic and international atmosphere. /ph3Job Description /h3pSupport analytical activities required for producing information and documentation suitable for preclinical and clinical development and registration of drug products, including excipients and intermediates, with particular focus on quality in accordance with GMP / cGMP. /ph3Responsibilities /h3ulliDeveloping pharmaceutical products (small molecules, new chemical entities, biological products, excipients, intermediates, Drug Products) in line with QRM principles by designing and evaluating the necessary activities both internal and c/o CRO: /liliDevelopment, validation and transfer of analytical methods /liliStability studies set-up and management /liliDrug products characterization studies /liliExtractables and leachables studies /liliStudies to support formulation and manufacturing process development (feasibility, refinement, scale-up) /liliExecute the development strategy of the assigned project /li /ulpContribute to the scientific understanding for the product development area. /ppPreparation and revision of technical documentation in line with quality and regulatory requirements and according to relevant internal procedures. /ppWriting / reviewing of regulatory documentation (CTD / NDA / IMPD / IND QA, Briefing documents for Scientific advice). /ppOperate according to the related SOPs, cGMPs, safety guidelines and policies as necessary to accomplish daily tasks. /ppSupport Change Control Evaluation. /ppSupport quality investigations (Deviations or OOS Complaints). /ph3Requirements /h3ulliAt least 2–3 years of experience in a similar position in a pharmaceutical company or CRO. /li /ulh3Type of Contract /h3ulliPermanent contract /li /ulpChemical contract. /p /p #J-18808-Ljbffr