This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. Job Description Monza site is a world class contract manufacturing and development facility, specialized in aseptic injectable drugs. Joining 2000 colleagues on site, the selected candidate will experience a smart, international, and fast-growing environment. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. The candidate will join the PDS Analysis Reviewer Team Leader in newly-built Pharmaceutical Development department and will perform required analysis to ensure that clients' requests are met according to SOP, GMP and GLP. Supporting the Analytical Development Supervisor in multiple task, the candidate will specifically be assigned the following activities: PURPOSE OF THE POSITION / RESPONSIBILITY: Based on the information received from the Manager and / or the Team Leader of the reference BU, it carries out the tasks and activities listed below for which it has been enabled by the appropriate training, in compliance with the company and departmental SOPs and the safety regulations in force. 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. C ontribute 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. 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. D epending on the schedule received from your manager, support the team by performing analysis. REQUIREMENTS AND QUALIFICATIONS: Diploma of chemical expert, Degree in Chemistry / CTF 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 GMPs Knowledge of laboratory concepts and computer programs Knowledge of data management and evaluation systems
