QA Documentation Officer
Badr City, Cairo
QA Documentation Officer
Badr City, CairoPosted 8 days ago91Applicants for1 open position
- 46Viewed
- 6In Consideration
- 3Not Selected
Job Details
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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.
- Dealing with EDA inspectors and regulatory daily follow-up and activities.
Job Requirements
- B.Sc. of Pharmacy or Science.
- 3 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.
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