Specialist Change Control & Validation

Responsibilities

• Manage change control implementation in accordance with QMS and cGMP guidelines (ICH/FDA/EMA)
• Coordinate site-wide changes within the GMP environment using electronic quality management systems
• Evaluate and process change control requests regarding manufacturing processes, cleaning procedures, analytical methods, and product transfers
• Provide QA oversight for validation activities, including process and cleaning validation
• Review and approve validation documents, strategies, risk analyses, and Master Batch Records
• Create and technically review Standard Operating Procedures (SOPs)
• Act as a Subject Matter Expert (SME) and interface for internal departments, customers, and Global Regulatory Affairs
• Represent the department during audits and inspections

Requirements

• Degree in Pharmacy or a comparable Natural Science field
• Several years of experience in a GMP environment, ideally within Quality Assurance
• Strong knowledge of process and cleaning validation and risk-based approaches (e.g., CPP/CQA)
• Comprehensive understanding of EU/US/JP GMP guidelines
• Proficiency with MS Office, SAP, MES, and LIMS
• Experience with electronic quality management systems such as TrackWise or Veeva
• Fluency in both German and English (written and spoken)
• Strong organizational, communicative, and independent working skills

Benefits

• 30 days of vacation
• Professional development and training opportunities
• Travel allowance and subsidized canteen
• Flexible working hours and wellbeing programs
• Employee discounts and stock programs
• Comprehensive insurance options including disability and accident insurance

About the Company

Takeda is a global, patient-centric pharmaceutical company dedicated to discovering and delivering life-changing therapies. Our Oranienburg site is a major manufacturing hub for solid dosage forms, supplying high-quality medicines to over 65 countries. We operate with the core values of Integrity, Fairness, Honesty, and Perseverance.