Job Detail

Summary:

The Quality Support Specialist, as a member of the Operations Quality Support team, is responsible for the quality review of executed batch records, forming an integral link between Packaging Operations and QA Post-Approval and supporting documentation according to customer and regulatory requirements including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines as well as Fisher Clinical Services Standard Operating Procedures (SOPs).

The incumbent will also take over calibration tasks of selected technical devices.

Responsibilities:

The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH is able to provide according to quality standards and timelines. After appropriate training, the Sr Document Control Administrator is able to complete the following tasks:

• Review of executed batch records


• Provide additional job related data such as environmental conditions


• Liasing with production and QA Post-Approval colleagues to ensure the above mentioned documents are according to customer and regulatory requirements


• Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals


• Provide support to improve documentation right first time metrics


• Ensuring any deviations or quality issues are appropriately documented


• Performing and/or administering calibration/maintenance tasks of selected technical devices


• Training and introduction for new team members including temporary staff if required

Your profile:

• Demonstrated ability to perform detail-oriented tasks


• Experience in the pharmaceutical industry, pharmaceutical production/packaging, quality control/quality assurance, medication handling, scientific field or equivalent


• GxP training or experience


• Bachelor’s degree in science or equivalent education or 3-5 years professional experience in GMP production


• Excellent communication and organizational skills


• Command ofGermanandEnglishat advanced level


• Ability to express detail in simple terminology, both written and verbal