Quality Systems Administrator
Autifony is recruiting a full-time (part time would be considered), permanent Quality Systems Administrator to join an exciting biotechnology company with a pre-clinical and clinical pipeline. We are looking for an experienced candidate to be responsible for the company’s Quality Management System and provide administrative support to the clinical team, maintaining essential documentation throughout the product development lifecycle and clinical trials process. The candidate will have relevant experience in a clinical development environment, and a good awareness of clinical research regulatory requirements- ICH-GCP, along with knowledge of the required documents and files supporting product development and clinical trials. Effective time management, self-motivation and organisational skills are key. You will join a friendly team and be working in a supportive environment.
The Quality Systems Administrator will report to the Head of Clinical Project Management and Chief project management Officer.
The role includes the following key activities:
Management of Quality Systems
· Maintain high level of knowledge and expertise in GCP, Quality Assurance and Regulatory compliance across multiple territories.
· In consultation with our external QA consultant, management and maintenance of the SOP and other QA documentation processes.
· Champion the evolution and oversight of the Quality Management System throughout the company, providing input to ensure it remains relevant for Autifony’s business.
· Contribute to the oversight of Autifony’s vendors according to SOPs and maintain vendor oversight folders.
· Act as the primary contact for Regulatory Authorities during inspections.
· Act as Company Archivist.
Clinical Trial Administration
· Set-up and actively maintain folder structures associated with product development and clinical studies on an ongoing basis (MPD/TMF Sponsor files).
· Liaise with internal and external clinical study team members (e.g. consultants, clinical Vendors) to ensure robust and timely preparation, filing, and archiving of clinical documentation according to SOPs.
· Support general project management activities including but not limited to setting up trial specific meetings, taking meeting minutes/providing agendas to the clinical team, tracking screening/enrolment across all sites, and maintaining study status trackers.
· Some requirements to travel to external contractor’s and investigational sites to review TMF files
· Opportunity to attend external audits with consultant auditors
- Previous experience working with SOP’s
- Previous experience of set up and TMF management.
- Previous clinical trial admin experience.
- Excellent attention to detail, highly organised and able to effectively prioritise tasks.
- Experience using Excel, Word, PowerPoint and Outlook.
- Team player with good interpersonal skills, and confidence to interact with all levels of the organisation
- Self-motivated and able to work well independently