Lab Manager

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