Quality Assurance Officer Operations

About the role

Novartis is hiring a Quality Assurance Officer for its facility in La Almunia de Doña Godina, Spain. The officer guarantees quality oversight over all GMP activities carried out at the site during working hours. The position is onsite and relocation support is not offered.

Key responsibilities

• Supervise the general hygiene conditions of the premises under its management.
• Help ensure the validation and qualification status of the production site, equipment, personnel training and quality documentation.
• Be responsible for the provisional release of batches for shipment.
• Work in shifts with other QA officers to oversee production and quality control activities.
• Archive and manage site GMP documentation, review batch records and ensure timely closure of manufactured batches.
• Maintain the local quality system in line with GMPs and corporate guidelines, and ensure compliance with GMPs and health authority requirements.
• Support the QP in preparing batch release documents and collaborate on writing, preparing and printing batch documentation.
• Take part in data compilation for product reviews, oversight of investigations and monitoring of resulting actions.
• Take part in self-inspections under the approved annual plan and in external audits.
• Ensure quality oversight during GMP activities across manufacturing, quality control, distribution and quality processes.

Required profile

• Scientific degree in Pharmacy, Chemistry or Biology.
• More than 1 year of experience in a Quality department.
• Strong affinity with and awareness of quality issues.
• Good organisational skills and attention to detail.
• Fluent English, spoken and in writing.

Required skills

• Solid knowledge of the quality system (GMP).
• Basic knowledge of regulatory requirements.
• Desired skills: collaboration, data integrity, leadership, operational excellence.

What we offer

• Base salary range in Spain of EUR 30,200 to 56,000, depending on skills, competencies and experience.
• Possible performance-based bonus.
• Insurance plans, retirement plans, wellbeing resources and global recognition programmes.
• Flexible and hybrid working options where possible, and at least 14 weeks of paid parental leave.