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View Cache (Job ID 13815679)
Employer Pe Global
Job Title Compliance And Audit Specialist
Description

Responsibilities of the role:

  • Responsible for internal & external cGMP & cGDP compliance.
  • Assist in the organizing and completing of supplier audits for new and existing pharmaceutical finished dosage forms and medical device manufacturing sites, monitoring of suppliers performance, investigation of supplier issues and support the release of finished product.
  • Ensure compliance with GMP, GDP, relevant SOPs with suppliers
  • Promote the maintenance of a safe, accident free and healthy work environment.
  • Ensure compliance & execute all activities to the company’s Quality Management System such as non-conformance investigations; deviations; change control, complaints, document control system, record retention & CAPA.
  • Contribute to audit findings trends and provide recommendations for improvement
  • Follow up on supplier corrective actions to ensure that the agreed appropriate actions are being carried out as committed by the supplier within the expected time frames.
  • Co-ordinate and maintain new and existing Quality & Pharmacovigilance agreements with suppliers.
  • Maintain familiarity with current regulatory trends, analyze and provide recommendations on how the Quality Standards or Systems should be modified internally & externally.
  • Support the Freight Forwarder Management Review meetings.
  • Support the non-conformance & complaint process.
  • Support the timely receipt and release of finished products.
  • Provide input to the Quality Management Review process & support the review meetings.
  • Manage new & existing SOPs for areas of responsibility.
  • Develop and implements Standard Operating Procedures.
Education and experience required:

  • BSc in a scientific discipline
  • 5 years in a cGMP facility with Production, Quality Assurance or Quality Control experience.
  • Experience of auditing in an international environment.
  • Ideally would have completed a Lead Auditor course or equivalent
Additional information

  • Be willing and available for international travel as required
If you are interested in this position, please forward your CV to catherine.osullivan@pegloabl.net or call Catherine on 0214297900

This job originally appeared on RecruitIreland.com
Location Cork
Date Added 65 days ago
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