Einleitung

Sterigenics Germany GmbH is part of the Sotera Health Group, the global market leader in the contract sterilization of medical products. The group employs approximately 2,700 people across 43 facilities in 13 countries. Our site in Wiesbaden operates under the German Federal Immission Control Act (BImSchG) and currently employs around 120 staff members.

Ihre Aufgaben

General

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations
• Preparation of laboratory budgets of expenditure and monitoring of the approved budget
• Provide excellent customer service by compliance with agreed / specified quality and delivery dates
• Manage existing staff resources, by cross training, to meet business need.
• Implement flexible support to validation department
• Plan and execute on time on staff resources and new investment to meet future business needs
• Planning and deciding on the introduction of new processes and technologies in the laboratory
• Receiving Customer and Regulatory audits in the laboratory
• Design and maintenance of the laboratory's quality management system
• Maintain laboratory certifications and accreditations
• Compliance with the interests of accident prevention and occupational safety
• Detect and prevent possible problems and foster attitude of continuous improvement
• Economic use and maintenance of machinery, equipment and other facilities in the laboratory
• Generation of protocols and reports
• Generate quotes and invoicing for laboratory service
• Processing of customer orders in the laboratory

Head of quality control (in some areas) in the context of § 14 German Medicines Act and § 12 pharmaceutical and drug manufacturing Regulation. Responsible for GMP according to the requirements of the pharmaceutical and drug manufacturing Regulation  

• Approval or, if it considers it necessary, rejection of raw materials, packaging materials, intermediates, bulk and finished products
• Evaluation of batch reports
• Ensuring that all necessary tests/checks are carried out
• Approval of specifications, instructions on sampling, test methods and other quality control procedures
• Approval of the external contract laboratories, as well as their monitoring
• Control of maintenance of the premises and the equipment of his department
• Ensuring that the necessary validations will performed
• Ensuring that the required initial and continuing training of staff of his department was carried out and will be adjusted to the respective requirements

Ihr Profil

Knowledge/Education and Training:

• A degree in a scientific subject (preferably a doctorate)
• Training Quality Management Representative / Internal Auditor
• Knowledge of workplace safety and accident prevention (training for first responders desired)

Experience:

• Extensive professional experience in the subject
• Experience in the pharmaceutical / medical device industry

Wir bieten

• Challenging and impactful role in a global leader in sterilization services.
• Flexible working hours and home office options.
• Professional development and internal training programs.
• Attractive benefits: company pension scheme, health management, JobRad, fitness studio, and more.

Weitere Informationen

Sterigenics Germany GmbH

Kasteler Straße 45
65203 Wiesbaden
http://www.sterigenics.com