Job Description
Job scope
- Prepare, review, and update cGMP documentation, including batch manufacturing records, Standard Operating Procedures (SOPs), and related documents.
- Initiate and manage change control records to support process and system improvements.
- Develop technical training materials and deliver training sessions to enhance production staff competency.
- Support the transfer of new products and manufacturing processes, including conducting field trials and validation activities.
- Author, review, revise, and approve technical and engineering documentation, such as User Requirement Specifications (URS), Functional Specifications (FS), Safety Data Sheets (SDS), and Piping & Instrumentation Diagrams (P&IDs).
- Lead the design, procurement, commissioning, qualification, and implementation of new manufacturing equipment.
- Collaborate effectively within cross-functional teams to ensure efficient, compliant, and successful pro...