Overview
Our 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.
Job Description
Support 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.
Responsibilities
* Developing 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:
* Development, validation and transfer of analytical methods
* Stability studies set-up and management
* Drug products characterization studies
* Extractables and leachables studies
* Studies to support formulation and manufacturing process development (feasibility, refinement, scale-up)
* Execute the development strategy of the assigned project
Contribute to the scientific understanding for the product development area.
Preparation and revision of technical documentation in line with quality and regulatory requirements and according to relevant internal procedures.
Writing / reviewing of regulatory documentation (CTD / NDA / IMPD / IND Q&A, Briefing documents for Scientific advice).
Operate according to the related SOPs, cGMPs, safety guidelines and policies as necessary to accomplish daily tasks.
Support Change Control Evaluation.
Support quality investigations (Deviations or OOS Complaints).
Requirements
* At least 2–3 years of experience in a similar position in a pharmaceutical company or CRO.
Type of Contract
* Permanent contract
Chemical contract.
#J-18808-Ljbffr