Quality Systems Specialist, North England, Contract- Ongoing, Competitive Pay Rate!
Key Responsibilities include:
- Oversee the global supplier qualification and assessment activities per established procedures, including initial on-boarding (including Quality Agreements), maintaining the supplier files and approved supplier list
Analyse and Facilitate Supplier Change Notifications, Deviations and Corrective Actions
- Support implementation and closure of supplier change notifications
- Provide support and expertise for global sites for any quality issues encountered from suppliers
- Facilitate root cause analysis and corrective actions of supplier quality issues (deviations) and support through on-site supplier visits, if applicable, for root cause analysis and verification of correction actions of supplier quality issues
- Work with the supplier directly to create correction action plans to address quality failures and issues
Develop and report on Key Performance Indicators
- Develop and report on supplier quality Key Performance Indicators (KPIs) driving to optimise performance, collation of supplier quantitative data for supplier risk assessments and prevent occurrence of any non-conformity relating to product, process or system.
- Support Operations, Supply Chain, Supply Chain QA, Procurement and QA leaders with the qualification and management of suppliers and service providers to ensure they consistently meet GxP requirements
- Represent Supplier Management in cross-functional teams to develop successful partnerships for consistent GxP-compliant supplier oversight.
- Partner with the Quality Compliance Auditing/Inspections team to ensure any requested data is available to support external audits.
- Represent Supplier Management in external audits by regulators/customers and ensure any Supplier Management related observations are addressed appropriately and timely. Support remedial actions (e.g. CAPA) with operational areas of the business.
- Identify, develop and implement strategic quality initiatives to ensure continuous improvement with respect to supplier quality performance.
- Acquire and maintain knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the sites.