Pds Analytical Development & Gmp Scientist Monza

Pds Analytical Development & Gmp Scientist
Monza
Lombardia, Monza

Performs chemical and biochemical testing and assays in accordance to approved methods and SOP, recognizing and reporting in a timely manner out of specification results or deviations.

- Performs basic maintenance and troubleshooting of laboratory equipment

- Performs and assist in method validation as directed by AD Supervisor

- Assist in managing new projects and activities such as implementation of new lab instruments and procedures

- Assists in trouble shooting and investigations as required by AD Supervisor

- Performs preparation of reagents and standard substances, related controls according to SOPs / methods in use and deals with the kitting activities

- As a result of specific training, he takes care of the visual inspection of the products for the part in charge of the analytical laboratory (AQL) according to planning within the department.

- Prepare laboratory documentation (eg notebooks, registers, etc.

).

**Requirements**:

- Good understanding of basic chemistry, chromatography, Gas Chromatography Immunoenzymatic techniques, biotech compound analysis and stability programs

- Experience in analytical development and methods validation in pharmaceutical (GMP/GLP) environment

- Good problem-solving skills and logical approach to solving scientific problems.

- Proficiency with the English language.

- Legibility in documentation as per Good Manufacturing Practices requirement.

- An awareness of regulatory requirements in the pharmaceutical industry (GMP/GLP and data integrity requirements), previous experience in pharmaceutical industry is strongly preferred

- Works well in a dynamic and result-driven team environment

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