Operator

Global Responsibility

Execute UpStream (USP) activities in the Cell Culture area of the production department, following operational procedures and GMP regulations.

Specific Responsibilities

• Execute the cell culture activities, according to process specifications and quality standards.
• Write SOPs related to the equipment and activities of USP department.
• Write batch records.
• Prepare the production equipment prior to its use and after it (cleaning, inactivation, etc.).
• Register all the productive activities in logbooks, batch records (BRs) or other documents, according to the Company’s quality procedures.
• Prepare culture means and process, filtering and sterilization solutions.
• Provide support in preparation activities, reconditioning and materials sterilization.
• Install and qualify equipment and support its maintenance, calibration and requalification.