• Establish and enforce GMP and quality standards (QA&QC)
manufacturing plant, including facility, production, packaging, labeling, testing, storage and distribution processes.
• Ensure Compny’s products’ quality, reproducibility and functionality in order to minimize any potential or actual risk to patients, ensure correct and effective usage of products and comply with regulations.
• Ensure compliance with international/local GMP guidelines for pharmaceutical products and IMC-GMP guideline for Medical Cannabis.
• Establish and maintain Quality Management System.
• Train staff in working in GMP environment/clean rooms, good documentation practice, safety, hygiene and other quality related issue, to ensure correct, effective and compliant operational implementation.
• Review, approve and support validation/qualification of infrastructure, processes and equipment.
• Write/approve Standard Operating Procedures (SOPs) and Working Instructions.
• Review status of process materials and ensure proper control, release and transfer of materials for production and sale through proper documentation and/or system.
• Ensure that accountability, lot numbering, tractability and destruction of raw materials, bulk, in-process and final products are managed as per approved SOPs in line with current regulations.
• Coordinate testing of materials/products and perform in-house control of starting materials, bulk and finished product as per approved specifications.
• Review analytical reports and Certificate of Analysis (CoA) of each product batch prior to its release.
• Approve batch documents and release of batches prior commercial stage.
• Coordinate and ensure that deviation investigations, complaints (related to quality) and Corrective and Preventive Actions (CAPA) are handled and closed in appropriate and timely manner.
• Ensure appropriate sanitation, pest control, change control and recall processes.
• Act as a contact person for Health Agency inspectors.
• Support and provide GXP input for Company Business strategy (GXP includes GAP, GMP, GDP, GLP).
• And any other task requested by the manager.
• Life science academic degree (Bsc.), licensed pharmacist, chemist, engineer, or physician.
• At least 3 years’ proven record in pharmaceutical industry in quality assurance field.
• At least 3 years’ experience in QA/QC qualitative and quantitative tasks in manufacturing plant.
• Strong knowledge in GMP and GDP regulations and guidelines.
• Experienced in quality assurance systems, QMS, validation/qualification, investigations, manufacturing methods, managing and/or responding to regulatory inspections.
• Proficient in written and spoken English.
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משרה מספר 6575658
