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Qualified Person

Sentinel

Posted on Sep 15, 2021 by Sentinel

Dublin, Ireland
Research
Immediate Start
€671 - €671 Daily
Contract/Project


Qualified Person
Rate: €671 PAY
Duration: 6 months
Dublin


The Qualified Person is primarily responsible for release of Nutrition, Chemo and Antibiotic products. They should oversight and quality assurance expertise and guidance of the compounding process in line with regulatory standards.


Responsibilities;


  • Ensure compliance with cGMP, corporate standards, site policies/procedures, regulatory requirements and industry standards.

  • Maintaining awareness of Quality Management Review and Annual Product Review reports, relevant deviations, CAPAs, change controls, Regulatory Authority Inspections and Product Complaints and the use of unlicensed drug components.

  • Investigations

  • Perform quality review of orders prior to manufacture.

  • Liaising with Dispatch and customer service to manage quality issues and timely customer service.

  • Inspection/Audit

  • Documentation Management

  • Quality System Management and Review

Skills;


  • Pharmacy Degree (or equivalent) in science-related discipline essential

  • Previous experience in a pharmaceutical company or equivalent-type role.

  • Ideally a minimum of two years' experience in a GMP regulated aseptic environment.

  • Experience of implementing changes and process development.

  • Previous experience in an aseptic manufacturing facility.




Reference: 1322282733

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