Quality - Quality System Specialist

2 months ago

Liverpool, United Kingdom Adecco Full time

**Quality - Quality System Specialist 12 Month Contract**

Within the Global Quality Systems and Compliance team, Supplier Management provides overall quality oversight of company suppliers who provide a service or material (including suppliers of direct materials, distribution & logistics and GMP services).

The position supports the business as usual activities and ensure compliance is maintained across the business and that suppliers are complaint ®ulatory requirements are met.

This position requires the ability to build strong relationships and collaborate effectively with all levels across functions within the organization.

Supports the establishment and management of the quality supplier management program
- Establish, harmonize, maintain and execute the company's quality supplier management program
- Follow the strategy, standards, global processes and procedures for supplier introduction and monitoring.
- 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.
- Provide relevant information for Material Review Boards and QC Material Specification set ups.

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 optimize performance, collation of supplier quantitative data for supplier risk assessments and prevent occurrence of any non-conformity relating to product, process or system.

Quality Partnerships
- 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.
- Collaborate with sites in US and Australia to ensure best practices and robust processes/procedures are in place.
- As required, provides training on Supplier Quality Management processes to other functions.

Continuous Improvement
- Identify, develop and implement strategic quality initiatives to ensure continuous improvement with respect to supplier quality performance.

Regulatory Intelligence
- 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.

Minimum Experience Requirements
- Minimum of 3 years of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred.
- Demonstrated experience of problem solving techniques within a Supplier Management/Supplier Quality environment
- Demonstrated ability to lead complex investigations/deviations
- In depth knowledge of the regulatory environment for the manufacture of drugs.
- Knowledge of global cGMP regulations and ISO standards preferred
- Demonstrated ability to understand data sets and drive to data-based decision

Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.

To speak to a recruitment expert please contact andrea redmond

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