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Supplier Quality
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Proclinical has teamed up with a market leading biotech know for is Scientific and operational excellence which discovers, invents, develops and manufactures medicines that treat serious medical conditions. They are an established company who have a global presence but are growing rapidly due to a healthy pipeline of new medicines. They are looking for a Supplier Quality expert to work on remediation activates across they QMS.
Job Responsibilities:
- Monitor performance/compliance issues identified across vendors. Perform Supplier Scorecard assessment and letters
- Participate and/or lead cross functional meetings and process improvement teams related to supplier improvement.
- Supplier Selection Process: Determine acceptability of suppliers for potential use by the company. Act as Quality Authority for approving Supplier Evaluation Reports, completing Supplier Assessments. Issue Material Safety Risk Questionnaires (MSRQ) to suppliers, review and approve responses, including BSE & TSE statements.
- Supplier Quality Oversight: Assist with preparation for supplier audits to include review of Scorecard, manufacturing deviations, product recall or reprocessing, or change controls associated with the supplier. Work with other sites using supplier to ensure full coverage and inclusion during audit. After paper-based audit completion provide a clear, precise report for Quality review. Supplier Audit reports are to include audit rating as well as reference to standard, regulation or Quality Agreement expectations or requirements (e.g. 21CFR210, ISO 9001, etc.)
- Supplier Master List: Manage Approved Supplier List in the company's Supplier Management System (SMS), including but not limited to: Supplier Name, Address, Supplier Role, Supplier Chain Management, Supplier Contacts, product codes. Approve Supplier Qualification and Approve Supply Chains in SMS.
Skills and Requirements:
- Knowledge and understanding of ISO 13485, ISO 14971, and 21 CFR 210, 211, & 820
- Lead Auditor certification (ASQ/CQA/ISO) preferred
- Strong auditing experience in medical device, pharmaceutical and/or contract manufacturing required
- Experience with Risk Assessments
- Excellent analytical and investigation skills
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 8141 316 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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