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Job Description
- 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
