Senior Vaccine Quality Assurance Specialist

About the role

EVA Pharma, a pharmaceutical company dedicated to improving human health and well-being, is looking for a Senior Vaccine Quality Assurance Specialist to join its Operations Business Division. The role leads QA activities in sterile production, maintains the quality management system and acts as the main QA contact with other departments.

Key responsibilities

• Lead QA activities within Sterile Production Operations, ensuring compliance with sterile manufacturing best practices and regulatory requirements.
• Manage and maintain the Quality Management System, integrating ISO standards for Quality, Environment and Health & Safety.
• Oversee Change Control, deviations, product recalls and mock recalls, annual product quality reviews and customer complaint management.
• Drive continuous improvement through digitalization and 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.
• Support performance management by aligning departmental activities with company KPIs and annual objectives.

Required profile

• Bachelor's degree in Pharmacy.
• 2+ years of proven experience in sterile manufacturing environments.
• Experience in biotechnology and vaccine manufacturing preferred.
• Proven ability to lead teams, manage complex negotiations and solve operational bottlenecks.
• Excellent interpersonal and communication skills with diverse technical and commercial stakeholders.

Required skills

• Strong knowledge of ISO standards and pharmaceutical GMP requirements, including EU, WHO and EDA regulations.
• Use of Minitab for statistical approaches.