R&D Analytical Scientist (Italia)
R&D Analytical Scientist (Italia)
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Job Description
Our clientChiesi Farmaceutici one of the top 50 pharmaceutical companies in the world with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff entrusted to IQVIA the recruitment of an Analytical Scientist - Developing pharmaceutical products -who can 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
IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).
#LI-CES #LI-DNP
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Employment Type
Full-Time
