Quality Systems Specialist

Sanovel İlaç

• Bachelor’s degree in chemical engineering, chemistry, Pharmacy departments
• Min. 5 years’ experience in Quality Assurance
• Knowledge with GMP requirement
• Experience in Deviation Managemet/CAPA Management/Risk Management
• Advanced English verbal and written communication skills
• High attention to detail
• Able to manage timelines with a sense of urgency and be flexible enough to adapt to changing priorities while maintaining a positive and collaborative attitude.
• Able to interpret problems and effectively prepare communication to key stakeholders with clarity, brevity, and accuracy.

JOB DESCRIPTION

• Deviation Management
• CAPA Management
• Risk Management
• Including, facilitating the closure of items with the applicable departments to ensure completion and timely resolution.
• Performing CAPA effectiveness evaluation based on quantitative and qualitative measurements
• Oversee supplier/vendor qualification program including conducting Quality Audits. Preparing the audit report and follow-up the CAPAs
• Ensure compliance with established SOPs, GMPs, and applicable global regulations and guidance.
• Performing internal audits and preparing the audit report
• Conducting or assisting with regulatory and quality training sessions.
• Preparing Annual Product Review Reports.