דרושים בתחום רגולציה

• Establish and enforce GMP and quality standards (QA&QC)
• Ensure Compny’s products’ quality, reproducibility and functionality in order to minimize any potential or actual risk to patients, ensure correct & effective usage of productsתcomply with regulations.
• Ensure compliance with international/local GMP guidelines for pharmaceutical products and IMC-
• Establish and maintain Quality Management System.
• Train staff in working in GMP environment/clean rooms, documentation practice, safety, hygiene.
• Write/approve Standard Operating Procedures (SOPs) and Working Instructions.
• Ensure that accountability, lot numbering, tractability and destruction of raw materials, bulk, in-process  &final products are managed as per approved SOPs in line with current regulations.
• Review analytical reports, Certificate of Analysis (CoA) of each product batch prior to its release.
• Approve batch documents and release of batches prior commercial stage.
Preventive Actions (CAPA) are handled and closed in appropriate and timely manner.
• Act as a contact person for Health Agency inspectors.
• Support, provide GXP input for Company Business strategy (GXP includes GAP, GMP, GDP, GLP).

• 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.