Department:Quality Unit

Location:Alexandria

Job ID:EE.QA.SSP.V

Quality Assurance - Validation Senior Specialist

Summary:

Follow-up and review implementation of all validation activities including: process/product, cleaning and computer system validation, quality risk management activities and change management activities before being presented to validation lead for final revision & approval.

Job requirements:

1-      Prepare validation activities plans & issue protocol that comply with regulatory requirements & 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 & 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.

7-      Provide periodical reports to superior with appropriate analysis regarding all validation updates to ensure effective & 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 or in Science.


Years of Experience: 4

Posting Date: 1 April 2021

Application End Date: 14 April 2021

Available Vacancies: 1

Job Level: Senior Specialist

Function: Quality Assurance

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