Quality Assurance Release Officer

About the role

Novartis is hiring a Quality Assurance Release Officer in Barcelona, Spain (hybrid, Level 3). The role ensures that commercial medicinal products placed on the market comply with manufacturing, testing and distribution requirements under current legislation, internal procedures and the Marketing Authorisation granted by health authorities. It covers review of samples and documentation and release for distribution.

Key responsibilities

• Manage quality aspects and projects within the area of responsibility.
• Ensure and support overall GxP compliance and compliance with Novartis Quality Management Systems.
• Review batch documentation before release by the Qualified Person (QP).
• Initiate and obtain the EU Batch Certificate for centrally authorised products.
• Assess transport of commercial medicinal products and evaluate cases involving temperature excursions.
• Manage and prioritise urgent requests and releases.
• Manage reconditioning of commercial batches in compliance with GMPs.
• Implement SLC in collaboration with Supply, DRA and other departments.
• Report and follow up on monthly indicators, and manage the documentation and sample archives.

Required profile

• Degree in Health Sciences.
• More than 1 year of experience in Quality Assurance and/or Quality Control.
• Native Spanish and good level of English.

Required skills

• Strong knowledge of GMPs and pharmaceutical manufacturing processes.
• GxP compliance.

What we offer

• Base salary range in Spain of EUR 34,700 to 64,400 per year, depending on skills, competencies and experience.
• Possible performance-based bonus.
• Insurance plans, retirement plans and wellbeing resources.
• Flexible and hybrid working options where possible.
• Minimum of 14 weeks paid parental leave.