Role and Responsabilities:
- Develop analytical methods on small organic (non-biological) and inorganic molecules for chemical and chemical-physical analyses of active ingredients, raw materials, process intermediates and finished products, including cytotoxic ones, and utilities monitoring.
- Validate and/or verify analytical methods on small organic (non-biological) and inorganic molecules to be transferred to the QC-Lab. in accordance with ICH, USP, EP, BP, JP, etc.
- Perform chemical and physical-chemical analyzes of raw materials, APIs and Finished Products, including cytotoxic ones, within GMP QC-Lab.
- Document the activities through the drafting of protocols, validation reports, verification and Method Transfer.
- Drawing up Standard Operating Procedures and Technical Reports as appropriate.
- Monitor External Laboratories for the development, validation, method transfer and routine application of QC analytical methods on small organic (non-biological) and inorganic molecules for chemical and chemical-physical analyses.
- Provide technical and scientific support to the analytical and pharmaceutical development projects.
- Support the QC-Lab., the QC Manager and the Quality Assurance Unit on chemical-analytical issues.
- Bachelor degree in Chemistry or Pharmaceutical Chemistry or similar is required;
- Previous lab-experience (5 years at least) in the pharmaceutical industry;
- Knowledge of cGMPs and/or GLPs.
- A highly motivated individual, with excellent time management skill;
- A very organised and methodical approach to tasks;
- IT skills: competent in using Microsoft Office, Empower, etc.;
- Proficiency in Italian and English (written and spoken).
- A level of flexibility is essential to meet varying workloads;
- Team player.