Be responsible for the management of DP17 Lyo group.
Make the plan of lyophilization according to DP17 production plan.
Organize train for lyophilization operator and engineer.
Manage the materials used in lyo process.
Manage the personal behavior on site.
Execute lyo operation, including but not limited to CIP/SIP, leak test, lyo process, filter integrity test.
Review the document of lyo process, including SOP and MBR.
Cooperate with other departments on deviation/change control/CAPA/risk assessment and other related quality activities: including initiate deviation, do deviation investigation in filling process scope, tracking deviation actions and ensuring compliance with deviation procedures; change control drafting, implementation and tracking; drafting risk assessment reports and organizing meetings to discuss them; and completing the tracking and closing of the loop on related quality activities.
Support engineering team on routine maintenance of equipment, maintenance or replacement of critical components.
Support the completion of activities such as calibration and validation of equipment.
Be responsible for the room management (5S) within working area.
Participate in other production activities within the plant.
Support other areas or post rotation if needed.
Compliance is ***.
Accept possible shifts change and job rotation.
Other works arranged by the line manager.