Quality Compliance Coordinator
The Quality Compliance Coordinator will support the Head of Quality and the Quality Department in all aspects of the Quality Management System, working across all functions supporting the Quality Management activities across the company and all GxPs e.g GCP, GMP, GDP etc. across all Diurnal Group companies including Diurnal Europe B.V.
Responsibilities: For Diurnal Group companies (including Diurnal Europe B.V.)
Oversight and Tracking Quality Management (QMS) Documentation and Processes
Ensure as outlined in the points below on-going completion, data entry, tracking and oversight for the QMS documentation across all GxPs. Responsible for maintaining and updating data across Audit, CAPA, Vendor, Change Control and Training tracking tools including excel spreadsheets, audit plans, tracking logs etc for all QMS related documentation. Identifying and raising any non-compliances and enhancements to the current processes to the Head of Quality.
- Organisation, tracking and requesting for auditing. Tracking of all respective documentation (audit plans, reports, certificates, letters, follow-up). Ensure that requests are sent out to auditors and auditees in a timely manner the return of all audit documentation to ensure compliance of the audit programme documentation. Inform the Head of Quality of potential non- compliances prior to the agreed deadlines.
- Ensure that the assigned auditors receive the required relevant documentation and logistical support/information prior to the audits in a timely manner.
QMS documentation and process oversight
- Maintain and ensure 100% for compliance for the uploading and archiving for all QMS documents across all the GxPs into the drives, electronic Document Management System and paper QMS filing system (as appropriate). Ensure that appropriate index lists are up to date both in paper and electronic files. Suggest and implement enhancements to the current documentation processes as appropriate.
- Support the development, build and maintain tracking tools for QMS documentation e.g. Audit, CAPAs etc.
- Input enhancements and suggestions to SOPs and Associated documents for QMS documentation processes and Tracking tools.
- Attend participate and support regular QMS meetings including follow-up of post-meeting actions. Assist in preparation of annual QMS reports.
- Support activities pre, during and post regulatory inspections as per Inspection SOP including logistics, documentation request support and post-inspection follow-up.
- Be fully available for the full duration of all inspection activities including travel to the inspection locations as required.
- Support of on-going inspection readiness initiatives as required.
SOP and Training Administration and Coordination
- Supporting the Quality department with Standard Operating Procedures (SOPs) and Associated Documents held within QualDocs (the SOP QMS electronic repository).
- QualDocs administration support and back-up for the key users.
- Ensure that manual SOP tracking for all read and understood training forms for external vendors is maintained and is up to date.
- Preparation of training documentation and presentations, update of training trackers with relevant data
Vendor Documentation Oversight
- Distribute, review, collate and file (supported by the responsible vendor managers), the oversight documentation across all GxPs.
Other QMS activities
- Set up, attend and follow up on relevant outcomes from QMS meetings.
- Perform all business-related activities that may be reasonably requested and as instructed by the respective Company Director or Head of Department
- Complete all the above activities within the framework and in compliance with DIURNAL SOPs and other documentation in force within the Company.
Requisite Skills, Experience and/or Qualifications
Quality Compliance Coordinator will require:
- Prior experience (minimum 2 years) working in accordance with GCP or other GXP area in a pharmaceutical, CRO, hospital or similar environment.
- Experience including administration of SOPs, Training documentation, CAPA tracking, Audit support and documentation administration.
- Knowledge and experience in quality management or clinical operations, be familiar with regulatory procedures and GCP.
- Highly organised, able to work on own initiative, with excellent attention to detail, able to produce high-quality work to agreed deadlines.
- Experienced in computer applications and business software including excel
- Excellent organisational, detail, written and verbal communication skills.
- Ability and to be self-motivated, work independently and innovative.