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Job Description
- Writing, change control, issuance, and organization of Standard Operating Procedures (SOPs).
- Organization and control of quality, compliance, and project related documentation.
- Lead utilization of an electronic document management system.
- Assists with preparation of regulatory filings and supporting documentation.
- Ensuring that quality operations are efficient, effective and meet target time frames from both a compliance and business perspective.
- Confirm that the audit procedures are properly carried out and assigned work schedules are maintained.
- Issuance, review, tracking, and completion of internal deviations and CAPAs.
- Consult with quality manager and personnel on better operational procedures to improve overall efficiency.
- Discuss system evaluation with quality manager, make appropriate recommendations and set timetable for improvement and correction.
Job Requirements
- Bachelor of science in Chemistry/Biology/Micro Biology/Pharmacy
- 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.
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