Qc Pds Analysis Reviewer
Thermo Fisher Scientific
Monza
25
Scarso
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Azienda: Thermo Fisher Scientific Monza
SPECIFIC TASKS / PRIMARY ACTIVITIES: - Implement the verification and evaluation activities of the analytical documentation issued by the laboratory in order to ensure the integrity of the data, through the correct programming of daily activities, the control of the progress of the activities, in compliance with the priorities defined by their manager and company quality standards. - Ensure the correct management of the relevant analytical documentation, from receipt, to control, archiving and traceability, according to current procedures and company quality standards. - Contribute to the optimal technical training of laboratory staff, both in the insertion phase and on the occasion of the introduction of new tools, in compliance with company standards. - Contribute to updating the procedures relating to the area of competence, by drafting and reviewing them as needed, in compliance with current regulations, laws and GMP standards. - Operate, under the supervision of the direct superior, in order to comply with the procedures defined internally on the basis of the NBF and the agreements established with customers. - Depending on the schedule received from your manager, support the team by performing analysis.
RELATIONSHIPS: INTERIORS - Production departments - Quality - Regulatory - Logistics - Business - TT - Technical Services EXTERIOR - Clients REQUIREMENTS AND QUALIFICATIONS: (A) ESSENTIALS Studies / Diploma / Training courses: - Diploma of chemical expert, Degree in Chemistry / CTF Technical and IT knowledge: - In-depth knowledge of the most common analytical techniques and required instrumentation (HPLC, UV-VIS, FT-IR. . ) - Knowledge of the Empower system for chromatographic data management - Knowledge and confidence on activities related to analytical transfer, validation of analytical methods and cleaning validation - Knowledge of company procedures and GM Ps - Knowledge of laboratory concepts and computer programs - Knowledge of data management and evaluation systems Professional experiences: - In the analysis laboratory of structured pharmaceutical companies Languages: - English Personality traits: - Flexibility - Good organization and planning skills - Listening and communication skills - Ability to work in a team
✔ Thermo Fisher Scientific