BeOne Medicines
10,000+ employees
Founded 2010
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
Manager, Qualified Person, Quality Assurance
🔥 0 minutes ago
🗣️🇮🇱 Hebrew Required
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BeOne Medicines
10,000+ employees
Founded 2010
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.
📋 Description
• Release/reject batches of registered and non-registered medicinal products for marketing in Israel including accompanying actions to comply with the Ministry of Health (MOH) procedures. • Ensure full compliance with Good Distribution Practices (GDP) and Good Manufacturing Practice (GMP) for the import and disposition decision of pharmaceutical products. • Prepare and update of controlled documents (e.g. SOPs, forms, non-governance) related to the local Quality Management System (QMS). • Handle quality complaints, product returns / defects • Support recall and mock recall process. • Support change control process for local QMS. • Manage local GMP/GSP suppliers and support BeOne Audit teams to assess the compliance of local suppliers, with competent legislative requirements. • Participate and facilitate inspections by regulatory authorities. • Stay current with changes in regulations and ensure the company adapts accordingly.
🎯 Requirements
• A minimum of 5 years’ experience in the pharmaceutical industry as a QP and a Quality Assurance background • Understanding of the pharmaceutical industry and legal framework. • Experience interacting with the Ministry of Health. • Strong knowledge of Israeli pharmaceutical regulations and standards regarding GDP/ GMP for the import and disposition of pharmaceutical products, and EU relevant regulations and guidelines. • Proficient in Hebrew and English. • Proficiency in various computer programs.
🏖️ Benefits
• Health insurance • Retirement plans • Paid time off • Professional development
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