Job Title:
Documentation and Release coordinator
Reports to:
Documentation and Release Section Head
location:
Cairo , Egypt
Affiliate/Department/Location
PGS
Position summary: describe in one or two sentences the primary purpose of the job
- Revision of batch records before product release to insure compliance with site procedures.
- Participate in document control process within PGS Cairo site.
Job Specific technical/Functional/Professional Competencies:
Batch records review and Release activities:
- Review of batch documentation and assure strict adherence to written procedures.
- Ensure applying of GMP rules during review of batch documentation.
- Participate in Creation Printing and Update of master batch records.
- Batch Record Review and Archiving.
- Revision of the product results of analysis on QIS.
- Participate in internal and external audit programs.
- Routing and Obsoleting SOPs and Documents on PDOCS.
- Activation, Obsoleting codes on E1 System.
Document Control:
- Routing and Obsoleting SOPs and Documents on PDOCS.
- Review and approval of Master Batch records, Cleaning SOPs and any other GMP documents as required.
- Participate in deviations investigations.
Other:
- Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
- Active implementation of Notification to Management procedures.
- Responsibility for compliance with Pfizer Quality Standards.
Experience and Knowledge
Bachelor degree in Science / pharmaceutical sciences.
Not less than one year in quality operations
Essential Personal Qualifications
- Good command of English both written and spoken.
- Knowledgeable with interpersonal learning.
- Communication, teaching and coaching skills.
- Logic way of thinking
- High analytical skills
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