Quality Assurance Documentation Officer
Badr City, CairoPosted 3 years ago109Applicants for1 open position
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Job Details
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Job Description
- Responsible for document control and record control activities.
- Complete responsibility for filing and archiving system for all GMP documents and for maintaining the robust documentation system in QA department.
- Issue, maintain and writing SOPs concerning QA department or other departments based on the latest updated references.
- Issuing, stamping and distribution of controlled documents and withdrawing the obsolete and invalid versions including: approved procedures and SOPs, specifications, methods of analysis, protocols and plans.
- Securing accessibility of all the documents available in 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 & Prepare Annual product review report.
- Preparing of Annual training plan (on job & cGMP) based on the training needs.
- Prepare Training matrix & follow up training implementation in QA department and other departments.
- Issuance, updating and control of master batch records.
- Issuance of different Products batches manufacturing records from the master batch records according to the production plan, allocating unique numbers and handling it to production department.
- Review Batch record and all related documents for release.
- Review packaging material art work and issue master packaging file.
- Any additional work that is requested by his superiors.
Job Requirements
- Suitable university degree preferred to be B.Sc. of Pharmacy or science.
- Not less than 2 years in a similar position.
- Male is preferable.
- Good understanding of the rules and guidance of ISO, GMP and GDP.
- Good English language.
- Good Computer skills.
- Interpersonal skills & communication skills.
