Job DescriptionMy Client is a Global Healthcare company and looking for a Quality Systems Specialist to Support their UK/Ireland/Nordic Compounding Sites
Due to COVID-19 the role will initially be home based with travel to any site as required once COVID-19 travel restrictions have been lifted to provide site specific QS support.
- The Quality Systems Specialist is required to support ongoing Quality Management Systems activities and Continuous Improvement projects during period of company growth. Role will initially be home based with regular interaction with sites across UK/Ireland/Nordic Compounding network.
- Proactively contribute to completion of activities to support closure of actions to comply with QS metrics deadlines having extensive experience of supporting, improving and maintaining Quality Management Systems and processes in a regulated environment, with a working knowledge of current EU and UK GMP requirements (EU GMP Annex 1).
- Strong analytical and problem-solving skills with experience of Root Cause Analysis and critical thinking with experience in Risk Management including analysis of product, process and system risks.
- Working knowledge and hands on experience of software tools to manage Quality Systems processes such as TrackWise, Agile, MasterControl, QPulse beneficial.
- Strong presentation, communication and negotiating skills, able to work with all levels of the organisation.
Quality Management Review (QMR)
- Identify, track, trend and report on performance metrics to identify opportunities for improvement.
- Support timely completion of actions arising from QMR.
- Support tracking, trending and analysis of audit findings and NCRs in TrackWise system ensuring cross site collaboration, initiation of corrective and preventive actions and timely closure.
- Support network wide audit responses and progress changes to the Quality Management System in order to maintain regulatory compliance.
- Support progression of Complaints in TrackWise with assigned Owners to ensure timely assessment of risk and complaint closure.
- Support the trending, monitoring and reporting of Complaints data to facilitate Quality Management Review (QMR) and cross site continuous improvement opportunities.
- Support update and maintenance of local Complaint Management procedures in line with Corporate, Compounding and Regulatory requirements.
- Support initiation, investigation, assessment of risk and progression of identified events in the NCR / CAPA / CPI / OOL /SCAR systems including TrackWise with assigned Owners to ensure timely closure.
- Support the trending, monitoring and reporting of NCR / CAPA / CPI / OOL / SCARs to facilitate Quality Management Review (QMR) and cross site continuous improvement opportunities.
- Support update and maintenance of local Non-Conformance and Corrective & Preventive Action Management procedures in line with Corporate, Compounding and Regulatory requirements.
- Support maintenance of effective change control process to ensure all changes are fully documented and impact of change evaluated across the UK, Ireland and Nordic Compounding network.
- Support trending, monitoring and analysis of Change Control metrics to measure process performance.
- Generate and maintain Change Control impact assessment tools, workflows and procedures to ensure all impacted products, processes, procedures, stakeholders and sites are evaluated and approved prior to initiating a change.
- Track and monitor the progress of initiated Change Controls to ensure timely completion to plan.
- Fully support the Quality Policy, Business goals and objectives by building quality in to all aspects of work.
- Support country / local initiatives and projects within the Compounding network eg. Integration projects, Value Improvement Projects, cross site changes, shared application development, commercial ventures and tenders.
- Support development and delivery of Quality Management Systems training.
- Identify new, or changes to existing, processes and systems to improve effectivity and efficiency of the Quality System maintain quality and regulatory compliance at all times.