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Senior Vaccine Quality Assurance Specialist

eva-pharma · 6th of October City, Egypt
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Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members. Job Summary: We are seeking a passionate and talented Senior Vaccine Quality Assurance Specialist to join our dynamic team. The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry. Key Responsibilities: • Lead QA activities within Sterile Production Operations, ensuring full compliance with sterile manufacturing best practices and regulatory requirements. • Manage and maintain a robust Quality Management System, integrating ISO standards related to Quality, Environment, and Health & Safety. • Own and oversee key QA processes, including Change Control, Deviations, Product Recalls and Mock Recalls, Annual Product Quality Reviews, and Customer Complaint management. • Drive continuous improvement through digitalization initiatives and the application of modern QA tools and statistical approaches such as Minitab. • Act as the main QA point of contact with Regulatory Affairs, Export, Supply Chain, R&D, and Laboratory teams to ensure effective cross-functional collaboration. • Support performance management by aligning departmental activities with company KPIs and annual objectives, with preference given to experience in biotechnology and vaccine manufacturing. Requirements • Bachelor's degree in Pharmacy. • 2 years+ of proven experience in sterile manufacturing environments. • Strong knowledge of ISO standards and pharmaceutical GMP requirements, including EU, WHO, and EDA regulations. • Demonstrated ability to lead teams, manage complex negotiations, and apply constructive problem-solving to operational bottlenecks. • Excellent interpersonal and communication skills with the ability to engage effectively across diverse technical and commercial stakeholders. • A proactive and innovative mindset, with a proven track record in system optimization.

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