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Quality System Specialist - 19404-1

Merseyside   •  £35000 - £40000 per annum  •  Contract/Temporary, Full time

  • 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).

Job responsibilities:
* 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.
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 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.
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 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


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