Specialist Qualification (m/w/d) Quality Control Compliance

Simtra BioPharma Solutions is seeking a Specialist Qualification (m/w/d) to join their Quality Control Compliance team. This role is based in Halle, North Rhine-Westphalia, Germany. The Specialist will ensure the qualified state of HPLC and GC systems, as well as analytical equipment, to meet regulatory requirements.

The role involves:

• Planning and performing timely maintenance, repairs, and qualifications of HPLC and GC systems and other analytical equipment.
• Selecting, commissioning, coordinating, and invoicing external service providers for maintenance, repair, and qualification support.
• Monitoring and controlling internal and external costs for equipment and system maintenance, repair, and qualification.
• Creating and updating all necessary documents for the area of responsibility.
• Implementing relevant Corporate Quality Procedures.
• Validating computer-aided systems in a timely manner.
• Supporting audits and inspections in German and English.
• Conducting specialist training courses.
• Continuously improving the overall system for equipment and system qualification.

Requirements:

• Analytical-technical vocational training, ideally supplemented by further training as a state-certified technician (m/w/d) or combined with a technical or engineering degree in chemistry, biotechnology, physics, or a comparable field.
• Professional experience in the field of GMP is desirable.
• Knowledge of GMP-compliant qualification and validation of equipment and systems is an advantage.
• Good analytical, technical, and IT understanding.
• Organizational skills and a responsible, independent way of working.
• Very good knowledge of German and English, both written and spoken.

Simtra BioPharma Solutions offers:

• Fair tariff-based remuneration including social benefits such as a 13th tariff salary, vacation pay, company pension scheme and additional long-term care insurance.
• In-house modern canteen with attractive subsidies.
• 30 days of vacation plus special leave.
• Weekly working hours of 37.5 hours.
• Job-Rad leasing.
• Good transport connections and free employee parking with e-charging stations at favorable conditions.
• Free company sports e.g. badminton, soccer and fitness courses.