- Assist Quality Director in all aspects of Supervision of Department and employees.
- Perform manufacturing investigations.
- Supervise QA team who carry out the detailed assessment of products and their components at different stages of production
- Train the QA team, and provide them with the documented quality standards as guidelines for their day-to-day work.
- Assist in regulatory inspections as needed.
- Evaluate addressed deficiencies for potential impact on compliance status while working with Manufacturing and/or QC to correct any noted deficiencies/inconsistencies.
- Monitor trends and identify problems in quality of Utilities, water system and environmental data and promote action regarding changes in processes, facilities, equipment and procedures.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Company Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs) and authority regulations and guidelines.
- Follows up the annual calibration plan.
- Evaluate CAPA responses to the assessment findings for adequacy, including root cause and timelines.
- Evaluate observation issues to management as appropriate.
- Follow up audits (as required) to confirm corrective actions are effective.
- Identify and manage continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
- Ensure compliance with all Company policies and procedures, including safety rules and regulations.
- Assist in the development, implementation, and enforcement of validation policies and practices.
- Coordinate validation activities between internal departments.
- Generate documentation to support the qualification of equipment, facilities, and critical utilities.
- Assure calibration system is current and maintained.
- Assess the performance of QA Staff, recommends further training and practice to enhance their competency.
- Monitor performance by gathering relevant data and producing statistical reports.

Job Details

Date Posted: 2016-08-16
Job Location: Cairo, Egypt
Job Role: Quality Control
Company Industry: Pharmaceutical

Preferred Candidate

Career Level: Management
Nationality: Egypt
Degree: Bachelor's degree

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