Vaccine Quality Assurance Section Head
Summary
Leads quality assurance for sterile vaccine production at Eva Pharma, owning the Quality Management System and key QA processes (change control, deviations, recalls, complaints) while ensuring GMP/ISO regulatory compliance. Drives continuous improvement through digitalization and statistical tools like Minitab.
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 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.
- 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 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.
Skills
As published by workable
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