Senior QA Officer

6 months ago


مصر, Egypt AstraZeneca Full time

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 GQA requirements.
- Implementation of Policies, Procedures and all local and external regulatory requirements.
- Prepare VMP and VMR
- Technical support and review of change control records
- Oversight the different qualification and validation activities
- Review Equipment qualification documents
- Review Faclitiy and utilities qualification docuemnts
- Participate and review the Technical risk assessment for technology transfer.
- Participate and review the cleaning validation plans.
- Participate and ensure the validation of all products and processes.
- Record and report deviations and incidents contribute in problem solving & investigation after any incidence and issues investigation report.
- Follow up CAPA implementation.
- 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.
- Prepares updates and revises the QA SOPS, Instructions and records.
- Participates is improvement projects and in preparation of CIPs.
- 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.
- Enhance communication between the quality and production.
- Identifies opportunities and areas for improvement.

**The role for project purpose, fixed contract 2 years**

**Years of experience : 3-7 years**

Experience in, and knowledge of, the pharmaceutical industry including experience in the following areas: General qualification and validation, Change management, risk management.

Practical knowledge in technology transfer

Practical knowledge Utilities qulification (HVAC, Purified water station)

Practical knowledge Facility / equipment Qualification

Experience in process and cleaning validation.

Experience in Pharmaceutical plant startup is preferred.


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