Supports internal customers in the set up and change management of stability studies, fielding stability-related queries concerning marketed pharmaceutical products and active pharmaceutical ingredients, and prepares submission-ready reports on stability data. May be involved on limited duration project teams.
Works closely with manufacturing sites to ensure that all stability commitments are met including receipt and placement of stability lots on condition.
Supports entry and administration of the Laboratory Information Management System (LIMS) where all stability data are stored including study creation, sample allocation and general system maintenance and change control. Years of Experience 2-5 years of relevant pharmaceutical experience; familiarity with GMPs and applicable regulations and guidelines (e.g. CFR, EMEA and ICH publications), and standard operating procedures; strong communication (oral and written) and teamwork skills; demonstrated critical thinking skills; close attention to detail and accuracy; demonstrated ability to work both independently
SAP, Change Management, Management, Information Management