Vendor Assurance Quality Engineer

Job Ref: J25604
Sector: Science
Sub-sector: Pharmaceuticals
Date Added: 22 February 2018
  • Loughborough, Leicestershire, England, UK
  • Competitive
  • UmulKulthum Ahmed
  • 0203 096 4529

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Vendor Assurance Quality Engineer12 months Loughborough

I am currently working with a science based technology company in Loughborough who are actively seeking a Vendor Assurance Quality Engineer to their team for a 12 month fixed term contract. You will support the Quality Management systems and provide the system support to the vendor team to deliver key objectives for quality.

Duties and responsibilities:

  • Audit work activities of processing production workers
  • Reading processing information such as worker logs, product processing sheets and specification sheets to verify that equipment is being operated and maintained according to quality assurance standard
  • SAP Audit Management
  • SAP CAPA Management
  • Completion of Supplier Audit Risk Assessment's (SARA) and
  • Supplier Risk Assessment Forms (SRAF)
  • Distribution of Supplier Questionnaires (SQ)
  • Vendor Assurance process mapping
  • Filing and archiving of Vendor Assurance files
  • Compile Weekly Vendor Metrics (e.g. CAPA's data summary table, CAPA's due and overdue data)
  • SCAR Data Project on ISM (Extract supplier information to compile reports and search for data trends)
  • Vetting of Change Management Reviews (CMR's)

Key Education & Knowledge Requirements

  • Degree in Chemistry or Pharmacy or related subject.
  • Familiarity with Quality System requirements, and the 'Orange Guide', equivalent FDA regulations and ISO EN 9000 and ISO EN 13485 requirements.
  • Knowledge of GMP/GCP Regulatory requirements.
  • Experience in GLP/GMP within a contract manufacturing environment of the Pharmaceutical industry.
  • Demonstrated competency in auditing for internal & external audits.
  • Demonstrated competency in customer negotiations and technical discussions is preferred.

To apply for this position, please email a copy of your CV

For more information regarding this position or any others, please call Umul on 0203 096 4529

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.