Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Operate different equipment in one of the functional areas assigned. Perform inspection and pack syringes. Assemble and inspect equipment in the manufacturing area to confirm operational status. Perform cleaning and sterilization procedures. Work is performed in aseptic or non-aseptic environments.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Inspect and pack syringes of biologic parenteral product.
• Clean, prepare and sterilize manufacturing equipment for parenteral use.
• Conduct equipment and facility inspections and raise situations that affect the operating, safety, and environmental conditions.
• Receive, inspect and verify materials availability to be used for production. Sample collection and processing as required by the process.
• Document, audit documentation and timely correct manufacturing electronic or paper batch record discrepancies.
• Perform cleaning operations according to the established procedures.
• Document process and equipment status in the area electronic or manual records.
• Monitor critical parameters and raise any deviation that could impact the operations to address accordingly.
• Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties..