Quality Assurance Officer

2 weeks ago

Giza, Giza, Egypt DataClin Group Full time 80,000 - 120,000 per year

Responsibilities

  • Participate in the development/update of the department's Standard Operating Procedures (SOPs).
  • Review prepared/updated SOPs.
  • Act as quality documents controller.
  • Maintains the Access Control Sheet.
  • Help in the assessment of vendors through the Vendor Assessment Questionnaire and maintain the Vendors List.
  • Act as an internal auditor.
  • Follow up on the proper management of identified deviations.
  • Review and approve Corrective and Preventive Actions (CAPAs) plans.
  • Perform other assigned tasks.
  • Follow up on the change control process.
  • Perform customer/employee satisfaction surveys and produce relevant reports.

Qualifications

  • Bachelor's degree in pharmacy/medicine.
  • Minimum 1 year of experience in quality assurance activities in clinical research or a relevant field.

Knowledge / Skills

  • ·Good knowledge of clinical trial processes and regulations (International Conference on Harmonization guidelines; ICH-GCP, as well as local regulations).
  • Aware of training models.
  • Fluency in English, both spoken and written.
  • Good computer skills.
  • Advanced communication and presentation skills.
  • Observant, perceptive, decisive, self-reliant, and act with fortitude.
  • Ethical, open-minded, diplomatic, culturally sensitive, and collaborative.
  • Open to improvement.

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