Validation Senior Specialist At European Egyptian Pharmaceutical Industries (EEPI)
Summary:
Follow up and review implementation of all validation activities including: process cleaning and computer system validation, quality risk management activities, qualification activities, and change management activities before being presented to validation lead for final revision and approval.
Job requirements:
1. Prepare validation activities plans and issue protocol that comply with regulatory requirements and company policy.
2. Witness and follow up validation run 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 and assess any changes will be conducted in site prior change execution and track execution of change actions.
5. Raise deviation and NCR risk assessment and review CAPAs relevant to validation activities.
6. Register and evaluate identified current or potential quality risks, suggest with key stakeholders proper mitigation actions and re-evaluate risk after their implementation.
7. Provide periodical reports to superior with appropriate analysis regarding all validation updates to ensure effective and accurate updated records.
8. Fulfill other related tasks as asked by management and as arising from the business.
Qualifications:
B.Sc. Degree in Pharmaceutical Science, Science or Engineering.
3-6 Years of Experience in related functions preferred Pharmaceutical Industry or FMCG.
Years of Experience: 3
Application End Date: 17 May 2023
Available Vacancies: 1
Job Level: Senior Specialist
Function: QA - Validation