Job summary :
The QA Specialist, as a member of the QA Pre-Approval team, is responsible for the quality review and approval of pre-executed batch documentation 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.
Review and quality approval of pre-executed batch documentation, change orders, job specifications, packaging orders, label printing requests, randomizations 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
Participation in Practical Process Improvement or other projects
Bachelor’s degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific roleCommand of English and German at professional level
Quality mindset and strong working knowledge of GMP and Good Clinical Practices Quality Systems Regulations and international quality standards
Ability to understand various operational processes
Demonstrated ability to perform detail-oriented tasks
High level of accuracy and efficiency
Excellent communication and organizational skills
Ability to express detail in simple terminology, both written and verbal
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.