API Technician (Shift based) - APICOM

at  AstraZeneca

THIS IS WHAT YOU WILL DO:

As a member of the APICOM Operations team reporting to the Shift Leader/Technologist you’ll carry out multi-stage cGMP active pharmaceutical ingredient (API) manufacturing processes utilising reaction vessels from 50Ltr to 6300ltrs in compliance with AstraZeneca EHS, GMP, and specific product standards.

DUTIES INCLUDE:

• Complete all relevant task-based documentation to meet EHS, GMP and standards, tasks such as initial material checks, charging/discharging and pack-off to equipment cleaning (pre and post manufacturing).
• Operating and cleaning process equipment according to standard operating procedures (SOPs)
• Complete all documentation following ALCOA+ principles.
• Closely monitor the operation of the plant and process both in the field and from the plant control system to ensure compliance with the process requirements.
• Set up routing panels for production, change over and cleans Manufacturing equipment to enable the smooth running of the plant.
• Charge powder and solvents reagents locally and from external tank farms.
• Perform sampling and testing activities throughout manufacturing process.
• Perform Cleaning and swabbing of all process equipment.
• Perform and document the results of all equipment cleaning sampling and inspections.
• Actively participate in any QMS record execution (deviations, investigations, etc) and support effective CAPA creation and closure.
• Provide operational input at capacity planning meetings such as processing risk assessments.
• Be active member of site Tier and Escalation processes