QA Validation Senior Specialist At Amriya Pharmaceutical
Company:Amriya Pharmaceutical
Department:Quality Assurance
Location:Alexandria
Summary:
Implement all validation activities including: Process/Product, cleaning and computer system validation, Qualification, & Calibrations, Quality risk management activities and change management activities.
Job requirements:
1- Prepare validation activities plans & issue protocol that comply with regulatory requirements & company policy.
2- Witness and follow-up validation runs execution, collect all necessary data and register and assess any anomalies.
3- Issue validation report, communicate validation outcome with management and concerned stakeholders and archive reports.
4- Register, communicate & assess any changes will be conducted in site prior change execution & track execution of change actions.
5- Prepare NCR reports, deviation and NCR risk assessment & review CAPAs relevant to validation activities.
6- Register & evaluate identified current or potential quality risks, suggest with key stakeholders proper mitigation actions & re-evaluate risk after their implementation.
Qualifications:
B.Sc. degree Pharmacy, or Science with relevant experience in Pharmaceutical Validation
Years of Experience: 3
Application End Date: 15 May 2023
Available Vacancies: 1
Job Level: Senior Specialist
Function: QA - Validation