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QC Document Control Senior Speci...

Al Andalous Pharmaceutic...
6th of October, Giza

QC Document Control Senior Specialist

6th of October, GizaPosted 1 month ago
123Applicants for1 open position
  • 78Viewed
  • 1In Consideration
  • 1Not Selected

Job Details

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Job Description

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.

 

Job Requirements

-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 .

 

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