Biotechnology Quality Assurance Specialist
6 days ago
Saudi Biotechnology Manufacturing Company (SAUDIBIO) is a leading biopharmaceutical company in the Kingdom of Saudi Arabia. As a prominent insulin manufacturer, we strive to maintain the highest standards of quality and safety.
Main Responsibilities:
- Ensure the quality of raw materials, in-process products, and finished goods through thorough sampling, analysis, and release processes.
- Perform QC analysis in accordance with microbiological best laboratory practices and regulatory requirements.
- Implement and coordinate laboratory tests, including qualification, validation studies, and routine validation requirements.
- Streamline testing procedures to increase lab efficiency and ensure compliance with established standards.
- Investigate quality issues, implement countermeasures, and provide feedback to department heads.
- Troubleshoot equipment and communicate effectively with teammates to resolve problems.
- Manage Quality management system activities for the Microbiology division, including Change Control, CAPA, Risk, Customer Complaints, Root Cause Analysis, Interval/external audits, etc.
- Audit processes to ensure standard work is followed and coach teammates as needed.
- Handle Incidents & Deviations in laboratory, OOT and OOS, lead investigations, and identify root causes and appropriate corrective actions.
- Train staff and provide technical support to teammates.
- Ensure all laboratory employees meet training requirements and work to maintain compliance with regulatory, environmental, health, and safety requirements.
- Introduce new products, procedures, and processes into the department or other departments.
- Comply with all General Laboratory Practices (GLP), safety requirements, and laboratory standard operating procedures.
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Biotechnology Development Specialist
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Quality Control Specialist
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