Quality Assurance Expert

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Job Description

About the Role: The Quality Assurance Expert is responsible for ensuring compliance and quality oversight throughout the manufacturing and release process of Drug Product (DP). This role plays a critical part in maintaining the highest standards of Good Manufacturing Practices (GMP), working collaboratively with various departments to ensure product integrity and regulatory adherence.

How You Will Contribute:

• Act as QA representative for routine GMP activities and company projects (including the implementation of a new manufacturing area)
• Ensure compliance with internal procedures, regulatory requirements, and industry best practices
• Lead and review deviation investigations, impact assessments, and corrective/preventive actions (CAPA)
• Evaluate and approve change controls, ensuring smooth implementation and compliance
• Provide quality oversight by supporting and guiding production teams directly on the shopfloor
• Conduct internal GMP audits and participate in regulatory inspections
• Prepare, evaluate, and approve controlled documents (SOPs, forms, specifications, etc.)
• Participate in batch record review and release activities
• Support continuous improvement initiatives and contribute to operational efficiency
• Provide training on GMP, GDP, and quality-related topics

Skills and Qualifications:

• Bachelor/Master’s degree in Engineering, Biotechnology, Pharmacy, or Quality Management
• 2-5 years of experience in a GMP environment within the pharmaceutical or biotechnological industry
• Strong understanding of GMP, FDA, EMA, ICH, and Pharmacopeia regulations
• Experience in auditing, inspection preparation, and deviation management
• Knowledge of biotechnological processes and manufacturing operations, and more specifically aseptic process
• Proficiency in MS Office; experience with quality systems such as TrackWise, Veeva and PAS-X is a plus
• Fluent in French; intermediate level in English

Personal Attributes:

• Detail-oriented with strong analytical skills
• Structured, organized, and able to manage priorities in a fast-paced environment
• Proactive and solution-oriented mindset with a continuous improvement approach
• Excellent communication skills, able to adapt to different stakeholders
• Team player, fostering collaboration across departments

Complexity and Problem Solving:

• Participate in operational decision-making
• Evaluate change requests and deviations in alignment with regulatory requirements and internal procedures
• Ensure compliance with validation reports, SOPs, and industry regulations

Why Join Us? At Takeda, we are dedicated to transforming patient care through innovative medicines and first-class support programs. As a Global Top Employer, we offer stimulating careers, encourage innovation, and uphold excellence in everything we do. Our inclusive and collaborative environment empowers employees to thrive and contribute to a brighter future for all.

LocationsCHE - Neuchatel

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time