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QA Documentation Officer

APEX Pharma
Badr City, Cairo

QA Documentation Officer

Badr City, CairoPosted 2 months ago
123Applicants for2 open positions
  • 97Viewed
  • 28In Consideration
  • 0Not Selected

Job Details

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Job Description

  • Preparing of QA department SOPs & procedures.
  • Writing official documents concerning QA in coordination with QA Head.
  • Preparing management review agenda, writing meeting minutes and final report.
  • Follow up of QMS requirements in all departments (quality objectives – KPIs – customer satisfaction...etc).
  • Issue, maintain and writing SOPs concerning QA department or other departments based on the latest updated references.
  • Review & Issue specifications, Test methods of analysis, MFPIs, protocols and plans & its update.
  • Issue site master file & quality management system manual.
  • Review packaging material art work and issue master packaging file.
  • Issuance & updating and control of master batch records.
  • Collect Annual product review data & Prepare Annual product review report.
  • Responsible for making statistical analysis for Annual product review.
  • Ensure IPCs inside the factory.
  • Issuance & Updating batch manufacturing records & batch packaging records.

Job Requirements

  • B.Sc. of Pharmacy or science.
  • Not less than 3 years of experience in a similar position.
  • Good understanding of the rules and guidance of GMP and GDP.
  • Good English language.
  • Professional using Microsoft office.
  • Excellent communication skills.
  • integrity and professional ethics.
  • Attention to detail.

 

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