Senior QA Officer

• 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.

Date Posted

29-Feb-2024

Closing Date

09-Mar-2024

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.