Job Description

• Responsible for document control and record control activities.
• Complete responsibility for the filing and archiving system for all GMP documents and for maintaining the robust documentation system in the QA department.
• Issue, maintain, and write SOPs concerning the QA department or other departments based on the latest updated references.
• Issuing, stamping, and distributing controlled documents and withdrawing the obsolete and invalid versions, including approved procedures and SOPs, specifications, methods of analysis, protocols, and plans.
• Securing access to all documents available in the QA department.
• Performing all the required document changes of the new versions for official documents of all departments.
• Gathering annual product review data, graphical presentation, & preparing the annual product review report.
• Preparing an annual training plan (on-the-job & cGMP) based on the training needs.
• Prepare a training matrix & follow up on training implementation in the QA department and other departments.
• Issuance, updating, and control of master batch records,
• Issuance of different product batches, manufacturing records from the master batch records according to the production plan, allocating unique numbers, and handing them to the production department.
• Review the batch record and all related documents for release.
• Review packaging material artwork and issue the master packaging file.

Requirements

• B.Sc. of Pharmacy or Science.
• 2:4 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.