Work Schedule
Other

Environmental Conditions
Office

Job Description

Quality Assurance Specialist, Quality Assurance Post-Approval

Job Summary:

The QA Specialist, as a member of the QA Post-Approval team, is responsible for the quality review and approval of executed batch records, certificate of packaging and supporting documentation according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs).

The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) is able to provide according to FCS quality standards and timelines. After appropriate training, the QA specialist is able to complete the tasks in Key Duties & Responsibilities chapter. Different tasks can have different training requirement and the QA specialist needs to be qualified.

• Review of executed batch records, creation of certificate of packaging
• Support QA Pre-Approval as required by line manager/workload: Review and quality approval of pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labelling requests, job specifications, packaging orders, LINKS reports, randomizations, SPA and supporting documentation
• Liasing with project managers to ensure the above mentioned documents are according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs)
• Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals
• Supply of information internally regarding the documentation review and approval process to support project planning
• Provide support to improve documentation right first time metrics
• Ensuring any deviations or quality issues are appropriately documented
• Inputting or analysing data for quality metrics
• Inform Supervisor of quality issues
• Maintain accurate records for all work activities
• Training and introduction for new team members and for other FCS departments (e.g. CS, CSOS etc.)
• Organising/executing/documenting GMP document archival (internal/external)
• Provide support for the larger Quality department which may include tasks such as:
• Participation in Practical Process Improvement or other projects
• Review and disposition decisions according to the agreed customer process for transport deviations and temperature excursions
• Supporting the review and approval of Pharma Unit Trackwise problem reports (PRs)
• Acting as a customer quality contact, answering client questions with regards to executed batch records

• Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, scientific field or equivalent
• GxP training or experience
• Demonstrated ability to perform detail-oriented tasks
• Bachelor's degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific role
• Excellent communication and organizational skills
• High level of accuracy and efficiency
• Ability to express detail in simple terminology, both written and verbal
• Command of English and German at professional level