Quality Assurance Supervisor (IPC) - Orchidia Pharmaceutical Ind.

About the Job

• Follow up GMP  regulations and procedures for quality management system
• Ensure timely completion of QA procedures, manufacturing, and packaging and in- process sampling.
• Report non-conformance  that are identified during  routine operations and in process
• Monitoring all phases of manufacturing , packaging of products in compliance with relevant standard operating procedures and manufacturing practices
• Review procedures and processes for accuracy and completion.
• Audit suppliers and vendors to assure their compliance  with GMP  and GSP regulation  and customer quality requirements
• Follow up on preventive maintenance plan and completion of maintenance tasks
• Approval of batch record & release of finished products for marketing
• Record GMP deviation reports and follow CAPA system
• Check and investigate customers complaints up to corrective and preventive actions
• Design internal auditing plan, conduct the plan and  follow up CAPA system
• Product description & specification
• Applied standard lists issue. 
• Communication with notified body in registration purposes and audit notification, CAR follow up
• Supervise , support the quality  assurance personnel
• Formulate technical training programs  and schedules based on   knowledge of identified training needs , company production processes, business systems , or changes in products  , procedures or services Follow up GMP  regulations and procedures for quality management system
• Ensure timely completion of QA procedures, manufacturing, and packaging and in- process sampling.
• Report non-conformance  that are identified during  routine operations and in process
• Monitoring all phases of manufacturing , packaging of products in compliance with relevant standard operating procedures and manufacturing practices
• Review procedures and processes for accuracy and completion.
• Audit suppliers and vendors to assure their compliance  with GMP  and GSP regulation  and customer quality requirements
• Follow up on preventive maintenance plan and completion of maintenance tasks
• Approval of batch record & release of finished products for marketing
• Record GMP deviation reports and follow CAPA system
• Check and investigate customers complaints up to corrective and preventive actions
• Design internal auditing plan, conduct the plan and  follow up CAPA system
• Product description & specification
• Applied standard lists issue. 
• Communication with notified body in registration purposes and audit notification, CAR follow up

Job Requirements

• Bachelor in pharmacy or science.
• Five  years’ experience in pharmaceutical operations , including three years in overseeing QA compliance
• Understanding of methodologies and best QA practices
• Knowledge of documentation reviews and requirements analysis.
• Ability to troubleshooting and resolving complex issues effectively.
• Excellent English, verbal / written communication
• Ability to work well through others
• Excellent computer skills

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