- Job title: Quality Systems Specialist
- Location: Liverpool
- Salary: £40,000k
- Contract length: 12 months
Within the Global Quality Systems and Compliance team, Supplier Management provides overall quality oversight of inter and intra company suppliers who provide a service or material to Seqirus (including suppliers of direct materials, distribution & logistics and GMP services).
* Follow the strategy, standards, global processes and procedures for supplier introduction and monitoring.
* 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
* 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.
* 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 of Seqirus.
* 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 Seqirus sister 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.
* 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.
Minimum Education Requirements
* Bachelor's degree in science or engineering related discipline. Advanced degree a plus.
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
* Ability to travel globally up to 10%
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
You must have the right to work in the UK. Learn more
- Agency: SRG
- Reference: BBBH129483
- Posted: 10th May 2023
- Expires: 7th June 2023