Document Control & Regulatory Compliance Specialist - Pharmaceutical

Eva Pharma - Giza, Egypt

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Experience Needed:
0 to 1 years
Career Level:
Entry Level
Job Type:
Full Time
Salary:
Negotiable
Education Level:
Bachelor's Degree at least
Languages:
Arabic, English
Vacancies:
1 open position
About the Job
  • Archive and retrieve quality records assigned to the Document Control, including external standards, technical reports, etc.
  • Check and submit all corporate documents to relevant departments on time.
  • Follow up document control systems in company in terms of issuing documents, submitting, canceling, and maintaining all master documents.
  • Review production batch record, packaging and raw materials analysis records according to GMP regulations for final release.
  • Ensure reference sample of each raw materials, packaging materials and finished product are correctly listed and in good storage conditions.
  • Ensure visual periodic check of reference samples is done in its due time.
  • Coordinate and prepare regulatory submissions for finished product.
  • Manage the final product and Raw Material submissions to regulatory authorities to obtain timely product approvals
  • Keep both manual and automated for documentation systems are within GMP and ISO guidelines
  • Maintain the processes for the development, approval, and release of product specifications and procedures, quality system process documentation and environmental management system documentation.
  • Participate in the preparation of master documents e.g. Site master file, company manuals.
  • Maintain and update an efficient documentation control system.
  • Prepare quality module of export files as per international regulations ( CTD files)
Job Requirements
  • Bachelor Degree in Science or Pharmacy
  • Good Command of English
About this Company

Established in 1997, Eva Pharma is one of Egypt’s leading pharmaceutical companies, built on the heritage of Les Laboratoires Delta, Egypt’s second oldest pharmaceutical company.

Today, Eva Pharma is the fastest growing pharmaceutical company in the MENA region,... (More)

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