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International QA Auditor (contract) - Edinburgh

International QA Auditor (contract) - Edinburgh

Job Title: International QA Auditor (contract) - Edinburgh
Contract Type: Contract
Location: Edinburgh, Scotland
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: QAAUD_1501091908
Contact Name: Nathan Wilson
Contact Email: n.wilson@sciproglobal.com
Job Published: July 26, 2017 18:58

Job Description

Job description

Carry out GXP audits for CMO, Suppliers, Service providers etc.

  • Prepare annual audit plan
  • Carry out GXP audits of suppliers, CMOs and Service providers
  • Carry out self-inspection of affiliates and departments
  • Support for hosting GXP audits
  • Review and approve stability, validation, tech transfer and technical protocols
  • Carry out GXP training
  • Regular Worldwide travel (50-70%)

Key requirements

  • A Life Science degree or equivalent
  • Broad experience of working in pharmaceutical QA GMP audit
  • Excellent working knowledge of international GxPs
  • Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes
  • Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids
  • Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
  • Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines

About you

  • Good interpersonal and communication skills
  • Sound technical knowledge of Pharmaceuticals
  • Good analytical and problem solving skills
  • Good writing and presentation skills
  • Team working and team development
  • Working experience of Quality Systems
  • Ability to operate in a "virtual" pharmaceutical environment
  • Maintain a high visibility and credibility with management and staff

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