Establish and enforce GMP and quality standards (QA&QC) for Company's manufacturing plant, including facility, production, packaging, labeling, testing, storage and distribution processes. Ensure Company'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 amd 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's business strategy (GXP includes GAP, GMP, GDP, GLP). And any other task requested by the manager.
Requirements:
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.