Jobs / Quality Assurance / Quality Control Jobs / QA Documentation Officer

QA Documentation Officer

APEX Pharma - Egypt - Cairo
Experience: 2 to 4 years
Salary: Confidential
Employment: Full Time
Gender: Female
Education: Bachelor's Degree","translations":{"name":{"ar":"درجة البكالوريوس","en":"Bachelor's Degree
  • Dealing with EDA inspectors and regulatory daily follow-up and activities.
  • 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.
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Post date: Today
Publisher: Wuzzuf .com
Post date: Today
Publisher: Wuzzuf .com