Scope: Assure level of Documentation compliance with company quality policy, MOH requirements, GMP and ISO standards requirements by Issue, review and maintain all documents in QC department. Close coordination with Quality Control manager to maintain quality system and detect areas for development and continual improvement in documentation system
Job responsibilities
1. Review, check and issue QC new SOPs and other documents.
2. Review and check SOPs and test methods periodically against approved specification and GMP.
3. Follow up the internal distribution cycle and control of all new and updated documents and records on weekly basis.
4. Internal audit on QC lab to insure implementation of SOPs, approved records and GLP instructions
5. Follow up with calibration, intermediate check & preventive maintenance plan, assure that all instrument is calibrated.
6. Establishing and maintain ISO documentation system
8. Prepare QC department & ISO Reports
9. Follow up with non-conformities & deviation
10. Uploading the Specification of raw material and finished product in SAP Program
12. Implementation , maintenance and improvement of the management system
13. Follow EDA comments regarding documentation needed for finished products and active raw materials.
-Bachelor Degree of Pharmacy or Science .-Experience required from (4-6 )years in the same role( QC Document Control).-Pharmaceutical industry experience is a must.-Fully awareness of GDP (Good documentation Practice) & GLP (Good Laboratory Practice ).-Well trained and experienced on GMP principles.-Fully awareness of ISO standards .-SAP user is preferred.-Excellent Communication Skills &Time management Skills .-6th October city resident and nearby are preferred .