Job Description

The position

Provide Quality Assurance support in data registration, deviation handling, change controls, trending of analytical results and trending of batch releases in order to maintain a healthy quality system in place.

Tasks and responsibilities

• Responsible for Quality Assurance archiving of batch documentation, master files, correspondence, licenses, complaints, recalls, rejections (destroyed goods), repackaging, deviations, change controls, validation/qualification documentation, and reference samples.
• Participate as assist to Lead auditor in audit program and self-inspection.
• Responsible for data registration for Animal Health complaints, Boehringer Ingelheim deviations, change controls, analytical results, and batch releases including imports from third countries.
• Responsible for the creation and maintenance of the Packaging Master to be sent to the consignment warehouse, as well as the Packaging Specifications to be sent to the CMOs.
• Responsible for the re-packaging process and act as coordinator for the actions and documentation.

Requirements

Required

• Bachelor’s degree with major focus on Pharmaceutics.
• 2 - 3 years of experience in Quality Assurance/Quality Control work.
• Fluency in English