Quality Specialist - Qualification

Responsibilities

• Manage and ensure GMP-compliant qualification of equipment, facilities, rooms, and systems in accordance with SOP, AMG, AMWHV, and EU-GMP
• Review, update, and approve QMPs, VMPs, and qualification documentation
• Ensure that only qualified and functional systems are utilized at the site
• Define and further develop qualification standards according to the state of the art
• Create, review, and maintain SOPs and coach employees on GMP-compliant documentation
• Provide technical leadership for qualifications, including site-wide consulting and support
• Participate in projects, PQR assessments, and technical assessments of changes impacting qualification

Requirements

• Degree in natural sciences (ideally a Master's) or an equivalent academic qualification
• Experience in the qualification of equipment, facilities, rooms, and/or systems
• Knowledge of production within a GMP-regulated environment
• Experience with local and global data integrity regulation requirements
• Very good German language skills and good English proficiency
• High level of initiative, organizational skills, and a team-oriented mindset

Benefits

• Attractive compensation and 30 days of vacation
• Company pension scheme and various insurance options (disability, accident, long-term care)
• Professional development and training opportunities
• Subsidized canteen, travel allowance, and employee discounts
• Health and sports programs, including a global wellbeing program
• Modern work environment with flexible options like long-term accounts

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything we do. Our mission is to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Our Oranienburg site is a major production hub for solid dosage forms, supplying high-quality medicines to over 65 countries.