I am currently recruiting a Quality Specialist for a Global Medical Device / IVD company based Worcester. The Quality Specialist will be support, maintain and improve on LIMs and QMS systems and process. It is a state of the art facility and is with a global power house, with unparalleled career progression prospects.
Key Responsibilities include.
- Support activities to ensure the quality management systems are maintained in line with ISO 17025 and forensic regulatory requirements
- Support external audit activities targeting no major findings
- Support and monitor thorough and effective non-conformance management practices within the laboratory
- Manage the document control and change management processes
- Support the internal audit program
- Record and analysis of monthly metrics and trend reviews of key quality processes for the laboratory
- Monthly reporting of relevant laboratory quality metrics including open quality items and laboratory sample TAT
- Provide training to all members of staff, as required, ensuring they are fully trained and knowledgeable on Quality Management principles, Good Laboratory Practice, Good Documentation Practice, CAPA, Root Cause Analysis, etc
- Involvement in PT and QC reviews
- Support necessary updates to Quality System requirements across all functional areas to align to new requirements in the new regulations
- Draft policies and SOPs tailored to ATOX business as necessary and drive to make live in the system.
- Support the wider QARA team in routine activities and new initiatives
- Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
- Perform other duties & projects as assigned
The successful candidate will possess:
- Degree in a Scientific or Quality based discipline
- Experience working in a ISO 17025 / GLP or GMP environment.
- Strong experience in LIM's, QMS systems
- Strong experience in OOS, RCA, CAPA's, Audits etc.
This position offers an excellent remuneration package, company benefits, holiday allowance and career progression.
Please apply online or for more information please call Paul Rees