Specialist Qualification Quality Control Compliance

About the Company

Simtra BioPharma Solutions is a premier CDMO that has been bringing sterile, injectable medicines to market for over 65 years. With over 2,000 employees, we support global customers with a wide portfolio of delivery systems, including pre-filled syringes and vials, with a focus on oncology therapeutics.

Responsibilities

• Ensure the qualified state of HPLC, GC, and other analytical systems to meet regulatory and customer requirements
• Plan and execute timely maintenance, repairs, and qualifications of analytical equipment
• Select, commission, coordinate, and settle accounts with external service providers
• Monitor and control internal and external costs for equipment maintenance and qualification
• Create and update all necessary documentation for the area of responsibility
• Implement relevant Corporate Quality Procedures
• Perform timely validation of computerized systems
• Support audits and inspections in German and English
• Conduct technical training and continuously improve the qualification system

Requirements

• Analytical-technical vocational training or a degree in Chemistry, Biotechnology, Physics, or similar
• Experience in a GMP environment is desirable
• Knowledge of GMP-compliant qualification and validation of equipment and systems is an advantage
• Strong analytical, technical, and IT understanding
• Highly organized and independent working style
• Very good German and English skills (written and spoken)

Benefits

• Fair tariff-based compensation including 13th-month salary and vacation pay
• Company pension scheme and additional long-term care insurance
• 30 days of vacation plus special leave
• 37.5-hour work week
• JobRad leasing and corporate benefits discounts
• Modern in-house canteen with subsidies
• Free company sports (Badminton, Football, Fitness courses)
• Relocation financial support