Requirements
Bachelor's degree in Pharmacy with 8+ 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. Excellent interpersonal and communication skills with a proactive and innovative mindset, proven in system optimization.
Description
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 Vaccine Quality Assurance Section Head 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 requirementsManage and maintain a robust Quality Management System, integrating ISO standards related to Quality, Environment, and Health & SafetyOwn and oversee key QA processes, including Change Control, Deviations, Product Recalls and Mock Recalls, Annual Product Quality Reviews, and Customer Complaint managementDrive continuous improvement through digitalization initiatives and the application of modern QA tools and statistical approaches such as MinitabAct as the main QA point of contact with Regulatory Affairs, Export, Supply Chain, R&D, and Laboratory teams to ensure effective cross-functional collaborationSupport performance management by aligning departmental activities with company KPIs and annual objectives, with preference given to experience in biotechnology and vaccine manufacturingRequirementsBachelor's degree in Pharmacy8 years+ of proven experience in sterile manufacturing environmentsStrong knowledge of ISO standards and pharmaceutical GMP requirements, including EU, WHO, and EDA regulationsDemonstrated ability to lead teams, manage complex negotiations, and apply constructive problem-solving to operational bottlenecksExcellent interpersonal and communication skills with the ability to engage effectively across diverse technical and commercial stakeholdersA proactive and innovative mindset, with a proven track record in system optimization