Quality Systems Coordinator

4 weeks ago

West London, United Kingdom Invicro Full time

**Quality Systems Coordinator**

Invicro is the world’s leading translational imaging company. Based in London, Boston, and New Haven, Invicro specialises in molecular and functional imaging studies to support medical and pharmaceutical research. The London site operates a unique clinical and pre-clinical imagining centre with state-of-the-art PET and MRI technology used to support clinical research.

**Main Responsibilities**:

- Operate and administer the Q-Pulse Quality Management System (QMS) including administration of user access and ensuring the processes operate effectively to support compliance within the business.
- Coordinate controlled documents to ensure appropriate quality and compliance standards are maintained.
- Support audit activities including coordination and tracking of self-inspections
- Preparation and presentation of Quality metrics to support management review and escalation processes.
- Provide QA support during client audits and regulatory inspections.
- Proactively participate in improvement processes linked to business needs and support GxP process improvement initiatives.

**Specific Activities**:

- Administration of the Q-Pulse electronic QMS, including management of user access and on-going user support as required in Invicro.
- Onboarding new starters and creating new accounts
- Provision of training relating to quality system workflows operating within Q-Pulse.
- Issuance of GxP documents as required.
- Review of completed GxP records
- Supporting archiving activities.
- Participate in GxP audits, internally and externally, to ensure Invicro Quality Standards are met, including periodic reconciliation of QMS elements
- Generation of Quality metrics and trend data to support the on-going management of compliance through the Quality Council.
- Tracking and coordination of non-conformances and audit findings against defined QMS timelines.
- Support audits/inspections of Invicro by third parties or Regulatory Authorities including management of the audit backroom ensuring prompt delivery of documentation and investigation of issues arising.
- Document management and distribution - global and local
- People management - job roles and title changes - new starters, changes
- Training management administration
- Other QA activities as required.

**Skills and Experience**:

- Significant relevant experience, gained within the pharmaceutical or healthcare industry
- Experience of the Q-Pulse Quality Management System (desirable)
- Proven understanding of the requirements of GxP as they relate to documentation and Quality Systems
- Proven ability to work across functional interfaces.

In order to succeed in this role, you will require strong interpersonal, communication and negotiation skills as well as a high level of attention to detail. This role reports directly to a Global Manager therefore strong organization skills with the ability to work independently and within a team is a must.

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