POSITION SUMMARY:

To support the QP function within Fisher BioServices to achieve department goals, including collation of documents for QP certification, generation of QP certificates and generation of QP declarations.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Bachelors degree in science or significant experience in a GxP environment
• Experience in review of documentation
• Ability to work independently but also in a team
• Experience within a Quality environment.

• Coordination and internal communication regarding the scheduling and completion of the documentation review and approvals.
• Supply of information internally regarding documentation review and approval process to support project planning
• Collation of documents for QP certification for all product types including ATMPs
• Generation of QP certificates as instructed.
• Generation of QP declarations as instructed.
• Documenting and Monitoring QP training
• To act as QP designee with completion of ‘Non QP’ releases as instructed.
• Maintain QP SOPs as requested
• Liaise with QP customers on routine issues.
• Work with QPs to improve team processes.
• Performs required duties as an approved Archivist
• Maintain QP Batch Registers
• Maintain Clinical Trial files and Product Specification Files for all product types including ATMPs
• Generation of Metrics as the need arises and support to improve quality metrics
• Inputting or analyzing data for quality metrics
• Inform Supervisor of quality issues