Job Reference: J5633631
Updated On: 03/09/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Quality Compliance Specialist to join a leading pharmaceutical company based in the Hertfordshire area. As the Quality Compliance Specialist, you will be responsible for ensuring GxP compliance across systems and site, through implementing continuous improvements.
Key Duties and Responsibilities1. As the Quality Compliance Specialist, you will be an expert in the maintenance of a Quality Management System and ensuring GxP compliance, continuously improving the quality systems and standards ensuring conformance to GxP principles.
2. You will prepare and compile Product Quality Reviews (PQR), schedule PQR meetings, and oversee creation and coordinate the collation of reports.
3. As the Quality Compliance Specialist, you will lead the Customer Complaints Processes through root cause analysis, implementing effective CAPAs and change controls.
4. You will maintain the Risk Register and Risk Assessment Master Tracker, conduct Gap Analysis of the QMS and oversee the review of existing Risk Assessments.
Role Requirements1. Educated to degree level in Life Sciences..
2. Proven industry experience in Quality Assurance and Quality Management Systems.
3. A working knowledge and practical experience with Product Quality Reviews.
Key Words: Quality Compliance Specialist / Quality Assurance / QA / Quality Management Systems / QMS / TrackWise / GxP / GLP / GMP / GDP / Sterile Biologics / Product Quality Reviews / PQR / Customer Complaints / Risk Management / Regulatory Compliance
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