Job Description:
Primary responsible for the post operation of the vial washing and sterilization, strictly follow the SOP to carry out the post operation, ensure the compliance of the operation and record in the production process, and timely report the abnormalities in the production. Receive shifts change and post rotation.
Other works according to the production demand and the arrangement of the line manager.
Key Responsibilities:
· Be responsible for DP16 vial washing and sterilization during the manufacturing phase including:
· Be responsible for preparation of vial washing and sterilization before production, including but not limited to size parts changing, equipment commissioning, vials transfer, batch and recipe initiating, etc.
· Be responsible for production of vial washing and sterilization, including but not limited to vial loading, equipment operation and monitoring.
· Be responsible for the work of vial washing and sterilization after production, including but not limited to residual vial emptying, production waste collecting, equipment cleaning.
· Be responsible for the SOP initiating, training and revising of working area, and initiate/maintain the MBR template per SOP.
· Be responsible for routine maintenance of equipment, including but not limited to instruments calibration, critical components maintenance or replacement.
· Be responsible for the room management (5S) within working area.
· Support the equipment qualification activity of working area.
· Participate in other production activity of plant.
· Support other areas or rotation if needed.
· Compliance is ***.
Other works arranged by the line manager.
Qualification:
· College degree or above, major in pharmaceutical related subject or industrial engineering or equivalent
· Have the ability of reading and writing of English, good English speaking is a plus
Experience:
· 2+ years’ related experience in pharmaceutical company
· Familiar with Syntegon filling line is a plus
Experience in formulation is a plus
Other Skills, Abilities and experience:
13· Good skills in using computer
· Excellent ability in analysis, communication skills and problem-solving. Work hard and carefully with strong team cooperation ability
· Pro-active, high sense of responsibility, self-discipline
Accept shift work and night shift