QA officer At AstraZeneca Egypt

Senior QA Officer

Job description:

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.

Job Requirements:

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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