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Senior Quality Assurance Specialist

MTBI-diagnostics
Badr City, Cairo
Posted 4 years ago
99Applicants for1 open position
  • 53Viewed
  • 5In Consideration
  • 1Not Selected
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Job Details

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Job Description

  • Preparing, reviewing and implementing quality assurance policies and procedures.
  • Identifying and resolving workflow and production issues.
  • Evaluate adequacy of quality assurance standards.
  • Devise sampling procedures and directions for recording and reporting quality data.
  • Review the implementation and efficiency of quality and inspection systems.
  • Investigate customer complaints and non-conformance issues.
  • Collect and compile statistical quality data.
  • Develop, recommend and monitor corrective and preventive actions.
  • Prepare reports to communicate outcomes of quality activities.
  • Identify training needs and organize training interventions to meet quality standards.
  • Coordinate and support on-site audits conducted by external providers.
  • Evaluate audit findings and implement appropriate corrective actions.
  • Prepare and Monitor risk management activities.
  • Responsible for document management systems.
  • Assure ongoing compliance with quality, medical devices, safety, and Environment regulatory requirements.
  • Assure ongoing compliance with In Vitro Diagnostic Directive (IVDD) Requirements.
  • Responsible for Qualification execution DQ/IQ/OQ in conjunction with relevant departments ensuring timelines met 
  • Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems, processes, or equipment.
  • Assist with validation activities performed by outside validation companies; perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.
  • Ensuring all instrumentation are compliant with the site calibration plan, non-routine calibration and fast acting in order to support production and maintaining all calibration documentations up to date.

Job Requirements

  • Bachelor Degree of Science or Pharmacy.
  • Preferably Industrial background. 
  • 3-5 years of experience .
  • Resident of Badr City or near by districts.

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