Aps & Sterility Specialist
Thermo Fisher Scientific
Monza
25
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Azienda: Thermo Fisher Scientific Monza
Your work will have real-world impact, and you’ll be supported in achieving your career goals. ** Location/ Division Specific Information** Monza (MB) ** How will you make an impact?** The resource will become part of a lively and dynamic team which is responsible for the aseptic validation process of products’ manufacturing in Monza site, by managing Aseptic Process Simulation (APS) documentation and supervising on the floor operations, in close contact with Client’s technical and quality teams, and in accordance with Regulatory guidance.
APS & Sterility specialist is a key element for the Company core business.
He/ She cooperates with Project Managers, Process Engineers and Client technical teams, within Monza site Quality Unit. ** What will you do?** - Analysis of technical documentation related to new protocols; - Issuing APS protocols and reports for, in accordance with GMP and corporate standards; Collect necessary information by involving relevant functions.
Processes object of APS are: manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes), as well as modern pharmaceutical technologies (i. e. fill finish processes under isolators); - Issue of manufacturing instructions (MBR) for APS batches; - Issue of technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions - Ensure correct management and archiving of documentation in line with GMP and internal procedures; - On-the-floor overlooking of manufacturing activities related to APS batches; - Support in preparation and update of APS department SO Ps. - Ensure that all relevant activities are adequately evaluated and managed through change control management - Support in preparation and participation to Clients’ and Regulatory audits with regards to APS activities. - Ensure that our client service delivery performance is maintained at the highest level, by building strong relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner. - Ensure an adequate reporting to the Area Management about potential issues ** How will you get here?** - Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / Biotechnology - At least 1-2 years of experience in pharma/chemistry industry ** Knowledge, Skills, Abilities** - English and Italian fluent - Knowledge of sterility assurance concepts - Knowledge of pharmaceutical legislation and national/international laws - Good social skills, team working - Propension to preparation of technical documentation - Critical sensibility, attention to details, precision - Organizational skills
✔ Thermo Fisher Scientific
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