Work Schedule
Other
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
Job Description
PURPOSE OF THE POSITION / RESPONSIBILITIES
Under the direction of the Department Supervisor and/or Team Lead, the incumbent performs the tasks and activities listed below, for which they have been qualified through the required training, in compliance with company and departmental Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and applicable Health & Safety regulations.
SPECIFIC DUTIES / PRIMARY RESPONSIBILITIES
Prepare filling lines within the Sterile Area at the start of manufacturing activities and monitor the proper product feed throughout the filling process. Perform integrity testing of 0.22 μm sterilizing filters (hydrophilic and hydrophobic), including both in-housing and disposable filters,
according to the frequencies specified in current SOPs and the instructions provided in the Batch Records. Perform dissolution and filtration of pharmaceutical products in accordance with the instructions specified in the Batch Records. Accurately complete Batch Records and maintain departmental documentation related to assigned activities. Perform raw material identification using the designated computerized systems. Perform cleaning, washing, and sterilization of reactors and tanks within the Injectable Manufacturing Department, in accordance with current SOPs and the weekly production schedule. Ensure the proper storage and preparation of materials required for connecting reactors and tanks, following current SOPs and meeting the timelines established by the weekly production schedule. Prepare disinfectant solutions for the routine cleaning of the Sterile and Pre-Sterile Areas in accordance with current SOPs. In coordination with Production Supervisors, transfer materials required for manufa
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