JA919 Quality Coordinator
Salary – C£35K + Bonus
We are currently recruiting for a Quality Coordinator to join our client’s production facility in Derbyshire. The successful candidate will maintain the integrity and continual improvement of the Site Quality Assurance Systems / Integrated Management Systems. To support the various business functions to develop and improve the effectiveness and efficiency of their systems and processes in delivering the quality objectives. To implement effective processes to detect measure and eliminate sources of product and process nonconformities.
- QA Arrangements – Ensuring the QA processes/activities necessary to ensure product and process compliance are identified, planned for efficiency, documented with agreed responsibilities, trained out, implemented and effective in use and continually improved where possible.
- QA processes and activities would include those required by the Quality (and other) standards that the site subscribes to (e.g., ISO 9001, 22716, and VMD/GMP) – e.g., Internal Audit Plans and Procedures, CAPA procedures, Final inspection protocols and FPQI procedures, Site Masterfile integrity, Quality Risk Assessments etc.
- Maintenance, development, and administration of the Quality Assurance Software.
- QA Measures – ensuring that measures are established and reported to demonstrate the effectiveness of those key QA processes.
- Protocols, Work Instructions, Records, one-point lessons etc. required to assure overall product checks are adequate, e.g., Torque checks, weight checks, Four Eyes Checks, Sampling protocols etc.
- Corrective Action Program – Maintaining data integrity into CAPA system.
- Ensuring CAPAs are raised when appropriate and correctly assigned to individuals for investigation and actions are recorded/completed with due dates.
- Monitoring investigation progress, providing guidance and expert support to the investigators, reviewing/approving the adequacy of corrective/preventive
- Complains– Primary complaint (QINS) planner for site – conducting initial research, requesting further info or investigation, initiating CAPAs where applicable and providing responses on behalf of the site into Agile.
- IMS Documentation – Plan and coordinate the format, structure and integrity of the IMS to ensure availability at point of use, document review, approval revision and issue control.
- Coordinate with relevant depts. to identify and develop the Policies, Procedures, Work Instructions, One Point-Lessons, Forms and Records etc necessary to ensure safety, and compliance with the applicable regulatory and quality standards (including. ISO and VMD/GMP).
- Internal audits – planning, conducting, recording main findings, follow up on actions, summarizing main findings.
- Ability to Prioritize and Organize Work, Effective Time Management, Logical reasoning,
- Excellent Verbal and Written Communication, Influencing Skills,
- Creativity, Thinking outside of the box
- Problem solving/root cause analysis,
- Able to lead effective meetings, /projects
- Organizational Process Planning, Packaging / Chemical Knowledge.
- Internal Auditor Skills, GMP experience is an advantage.
- Competent and confident in the use of Microsoft Office Suite and other computer-based information systems.