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QA/GMP Compliance Expert

QA/GMP Compliance Ex

United Kingdom,
London
Permanent
22 March 2023
  • Improve and monitor adherence to all company policies and procedures relating to cGMP, SOPs and Health, ICH Q10, and FDA 21 CFR 820 requirements.
  • Planning, coordinating and supervising inspections by the business, authorities and clients in the preparation for front office and back office activities
  • Conduct internal and external audits, Manage Deviation, CAPA, Change Control arising from self-inspections and the closing thereof. Analysing the results of self-inspections and making suggestions for improvement
  • Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level.
  • (Co)-Managing Technical Agreements with customers and suppliers
  • Implement vendor qualification program for the clients.
  • Benchmarking of operations with best practices within Global operations and Pharmaceutical industries and initiating improvement actions under this benchmark
  • Administrative systems, charts, procedures and reports
  • Keep track of compliance regulations and advise the organization
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