Job Description
Role & Responsibilities
- Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
- Support the development and implementation of operational procedures, including SOPs, master batch records, and work instructions.
- Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup.
- Collaborate with Engineering, Maintenance, and Validation to ensure timely calibration and validation of production equipment.
- Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).
- Maintain thawing and formulation rooms and ensure adherence to stringent requirements, with flexibility for the execution during off-hours. ...