on FDA requirements and/or Hikma proposed changes. Completes regulatory portion of Annual Product Reviews (APRs). Reviews..., amendments, and other correspondences to FDA. Keeps Hikma's Ruby database current for all injectable products. QUALIFICATIONS...
Job Summary: The Aseptic Technician is responsible for training staff on gowning procedures, training staff on proper aseptic technique in ISO 5/7 classified rooms, performing random personnel environmental monitoring, completing aseptic ...
DESCRIPTION In accordance with Hikma SOP's and cGMP's, the Production Operator II is responsible for the inspection...
JOB PURPOSE: Under the general direction of Operations Management, the Operations Group Leader provides support to Manufacturing. Provides the necessary leadership to achieve product quality, cost control, cGMP compliance, safety, and th...
JOB PURPOSE Using company guidelines, the Filling Operator I is responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitization, equipment clea...
This is a 1st Shift Position Using company guidelines, the Filling Operator I is responsible for the full spectrum of duties in controlled filling and ancillary rooms. This may include but is not limited to: set-up, operation, sanitizatio...
JOB PURPOSE Maintains the aseptic filling cores and controlled preparation rooms in accordance with company SOPs, cGMPs, and departmental working directives. KEY ACCOUNTABILITIES Must maintain gown qualification. Understands and comp...