Quality Assurance Supervisor At Astrazeneca egypt
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