In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations where applicable, and the organizational quality level established for medical products
Responsibilities
Qualified Person Responsible Pharmacist of the importer.
Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
Responsible for batch releases of registered and non-registered products.
Review PQRs and full batch records provided by the partners.
Execution of additional supervisors instructions and tasks accordingly.
B.Sc. Pharmacy degree, certified pharmacist by MOH. Pre-approval by the MOH as a certified QP.
Englishnative proficiency. Hebrewhigh level.
Experience with Microsoft Office and taking an active role in external audits.
