QA Officer
6 days ago
Putting down GMP SOPs, instructions and records.
Ensuring that QCM documents updates are reflected into AZ Egypt QMS, i.e compliance of local GMP documents with AZ GQO requirements.
Implementation of Policies, Procedures and all local and external regulatory requirements.
Performs QA tours in the production& operations area to:
- Revises the in-process products’ documents to ensure that they are manufactured / packed as per the latest approved BR without any changes or deviations.
- Observes Production Operators behavior, awareness, and proper documentation throughout production steps and that data are clearly and directly recorded in the Batch Record.
- Checks the cleanliness and clearance of rooms, equipment before start up and during operations.
- Checks the environmental conditions (Temp, R.H. & Diff. Pressure) during the operation in accordance to the specifications of each product.
- Enhance communication between the quality and production.
- Identifies opportunities and areas for improvement.
Record and report deviations and incidents contribute in problem solving & investigation after any incidence and issues investigation report.
Follow up CAPA implementation.
Participate and ensure the validation of all products and processes.
Check the calibration of equipment / instruments used in different operations.
Performs internal audit on the site and external suppliers as a part of the audit team.
Acts as a GMP trainer for personnel in the site.
Acts as a system owner for different quality systems as per internal department.
Responsible for MOH release system, contacts and hosts the inspector, collects all documents needed for sampling and release.
Participate in preparing Annual Product Review reports.
Prepares for the quality council meeting.
Prepares updates and revises the QA SOPS, Instructions and records.
Participates is improvement projects and in preparation of CIPs.
Ensure the destruction of production waste.
Use SAP in accordance with the assigned QA tasks.
Following SHE policies, Adhere and follows Code of conduct.
Ensure own work is compliant with health, safety and cGMP.
**Contingent role for project purpose, fixed contract 2 years**
**Years of experience : 2-5 years**
Experience in validation and qualification activities is a must.
Experience in Pharmaceutical plant startup is preferred.
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