Amira Ezzeldin

• Performed thorough and detailed review and ensure accuracy, and completeness of more than 100 pharmaceutical product batch files per year, and release batches of conforming results for sale.
• Monitored any problems that arise during manufacturing process, ensuring only safe medication to be released for customer use.
• Performed thorough review and conform release of batch data for more than 6000 batches per year on EDA (Egyptian Drug Authority) website.
• Established new marketing product code after any change in product (price, expiry date, ...).

• Review and release of conform batch files.
• Review and conform release of batch data on EDA (Egyptian Drug Authority) website.
• Data collection for APQR (Annual Product Quality Report).

• Review and present data required for (MOH (Ministry of Health) inspection - currently EDA (Egyptian drugs authority) inspection - for more than 50 visits per year and handle any requests.
• Review document and samples of more than 100 batches per year for sending to Ministry of Health laboratories.
• Complete Certificates of Analysis for more than 100 batches per year to ensure compliance with relevant export countries regulations.

• Handled day-to-day running of Quality Control Sector Head office, ensuring high levels of productivity and progression.
• Performed document control for General Quality Control Sector documents, according to recent ISO specifications.
• MOH inspector visit data collection, and any other requirements.

- Office Management of Quality Control Sector Head.

- Document collection and organization for Ministry of Health visit.

- Document review of In-Process Control follow-up records.

- Process validation team member for Quality Control Sector.

• Preparation, research and data collection of product registration requirements by Ministry of Health for over 150 products.
• Creating periodic reports about product status and procedures needed.