Senior Quality Assurance Specialist

A multinational company located in Nasr City is looking for Experienced Senior Quality Assurance (Full-time).

Qualification: Bachelor of Pharmaceutical / Science / Medicine.

Experience: 4 years in Quality Assurance with minimum 1 year experience in clinical trial.

Skills:

Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds.

Knowledge of international regulations for quality systems and compliance.

Ability to identify problems, and initiate corrective actions and preventative actions.

Responsibilities:

1- Related to Quality Department:

1.1. Document control system:

-Follow up on QA specialist in newly issued/ changed SOP to be matched with issue/change document request.

-Issue document master list, record master list and external document master list

-Follow up on QA specialist to print, stamp all issued Sops and document retrieval

- Review all issued logs as to be matching to the current status

-Filling all quality related document related to the project.

2.2. Auditing System

-He/she will be part of the team during implementing internal/external audit matching to audit plan developed by QA Manager

-Follow up on QA Specialist in writing audit report that to be matching to the audit checklist and the non-conformities determined during the audit.

-Follow up on QA specialist in documented CAPA actions.

-Follow up with QA Manager in implementing CAPA actions.

2- Related to Clinical Department:

- Implement Audit plan developed by QA manager and follow the responsibility actions mentioned in audit system section.

- Follow up on QA specialist in recording deviation/violation log.

- Follow up on status of TMF

- Follow up on training implemented program during the study

- Part of the team during performing final quality check after site close out visit

- Part of the team during follow up visit on source document after passing aligned retrieval period

Job Requirements: Knowledge of GCP principles, Clinical studies procedures and guidelines.

If you are interested, please send your CV to [Confidential Information]

Quality Assurance

Quality Control

QA

Pharmaceutical

Chemistry

Science

Biology

Micro

Quality systems

Compliance

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