Documentation Officer At APEX Pharma
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.