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Quality Control & Assurance




quality-control

  • To design an appropriate Quality Management System (QMS)
  • To implement any corrective and prevention actions
  • To review and approve all documents (e.g. Validation and Test Plans, Test Protocol and Validation Summary Reports…), Validation Master Plan.
  • To review and provide approve Standard operating procedures.
  • Quality service according to guidelines stipulated by regulatory bodies.
  • Independent review of  DATA
  • Comprehensive review of calibration procedures;
  • Review of Laboratory Investigation Procedures for Deviation and Out of Specification handling meeting FDA regulations.
  • Implementing Effective Internal audit program with effective CAPA system.
  • Co-ordinating inspections and audits by regulatory bodies and customers
  • Database audits
  • Site qualification/audits
  • Quality Systems audits
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