Quality Assurance Supervisor

3 days ago


مصر, Egypt AstraZeneca Full time

Perform Internal and external audits in addition to audit program planning. Prepares the audit and observation reports. Follows up audit action plans.
- Batch records revision and release of AstraZeneca Egypt products to Egyptian market as deputy for Quality Lead.
- Prepares, updates the QA SOPs, and review other functions GMP SOPs, instructions, records and logbooks.
- Participate in setting the site’s GMP training plan according to business priorities. Provides GMP training to site employees.
- Follows up and support the embedding of quality culture by ensuring the right behaviours are followed at all stages of operations, awareness, and proper documentation.
- Address trends of GMP observations and incidents. Contribute in issuing the site’s improvement plans.
- Contribute in problem solving & investigation after any incidence.
- Follow up CAPA implementation.
- Participate and ensure the validation of all products and processes. Follow up of validation and qualification activities till completion and issuing final reports
- Responsible for the safe archive and maintenance of validation and qualification documents in accessible protected cabinets.
- Participate in preparing Annual Product Review reports.
- Contribute in the Quality Management Review meeting.
- Participate in Lean Project as per the site’s Lean plan.
- Support new QA officers by training for GMP and SHE
- Present the QA in the site daily Tier 3 and monitors the effectiveness of the QA daily GENBA tours in Production.
- Following SHE policies, Adhere and follows Code of Ethics
- Ensure own work is compliant with health, safety and cGMP
- Perform all the required activities in accordance with the local regulatory requirements.
- Receive and Respond to the updates of the regulatory decrees and laws according to the local instructions.
- Ensure that imported bulks, API’s and finished goods packed from imported bulks are released to the local market according to the requirements of the health authorities.
- Perform all required risk assessment studies in accordance with the local procedures.
- Contribute in the identified site quality risks
- Special tasks for the person
- Contribute in preparation of the Plant Master File to be reviewed and approved by the Quality Lead
- Experience: 5 - 7 years in Quality function



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