Quality Engineer - Vendor Assurance

Job Title: Quality Engineer - Vendor Assurance
Contract Type: Contract
Location: Leicestershire, England
Salary: Up to £12.69 per hour
Start Date: ASAP
Reference: 71135-PHARM-JHY_1519398723
Contact Name: James Harvey
Contact Email:
Job Published: February 23, 2018 15:12

Job Description

Job title: Quality Engineer - Vendor Assurance
Job type: Initial 12 month contract + potential extensions
Sector: Pharmaceuticals
Location: Leicestershire, East Midlands, UK
Salary: £12 - £13 / hour


- My client is a highly-respected, global technology company with a vast product
range across multiple business units
- I have an exciting opportunity to work with them on a contract basis within their
pharmaceutical division as a Quality Engineer
- The Vendor Assurance Quality Engineer role supports the Quality Management System
and provides the system support to the Vendor team to deliver key objectives for
- Ensuring appropriate internal communications and developing compliance
understanding within the Vendor team

Key duties & responsibilities:

- SAP Audit and 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. CAPAs data summary table, CAPAs 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 (CMRs)

Education / experience required:

- Degree in Chemistry or related area
- 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
- Previous experience in GLP/GMP within a contract manufacturing environment
- Experience supporting internal & external audits
- Demonstrated competency in customer negotiations and technical discussions

If you are interested in this role please apply online

If you would like to hear about other opportunities in the Life Science field please contact James Harvey on 01737 236 706 for a confidential discussion