About the role
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.
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.
