QA Validation Expert

This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department.

Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release process.

QA Expert

• Acts as QA representative for both routine GMP activities and company projects.
• Acts as the Quality partner within Production Unit Team, the Quality Control laboratories, Warehouse and Engineering/Maintenance/Validation departments as applicable.
• Ensures quality and integrity of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.
• Supports and works in line with the "QA on the shopfloor" requirements (for example through GMP audits or events management).
• Responsible for quality aspects during the Validation Activities (routine and projects)
• Shall promote and be involved in Continuous Improvement.
• Understands and applies Takeda EHS guidelines and commitment policies, takes care of its own safety, reports risk situations and improvement opportunities to supervisory personnel

The job holder can act as back up of other QA Experts and QA Lead as requested.

Critical / Key skills (Compétences critiques / clés) :

• At least 2 years of experience in an GMP environment
• University degree in Engineering, Biotechnology, Pharmacy, and Quality Management applied to

industrial process or equivalent experience in pharmaceutical and /or biotechnological companies

Language & IT Skills (Compétences linguistiques et informatiques):

• French fluent,
• English read, written and spoken.
• Values of Integrity, Fairness, Honesty, Perseverance as a natural way of working.
• Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards