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
People Management
· Develop competency of the laboratory personnel
· Determine short-term need of personnel needed for process execution and ensure effective cross-training
to cover holidays and sickness leave
· Participate in the recruitment ensuring staff have the required skills/experience
· Co-determine the training of laboratory staff and follow the established training plan
· Conduct appraisals for laboratory personnel and define their goals
· Evaluate the performance of laboratory staff (vacation, sick leave, working time)
· Ensure discipline and compliance with the values
· Promote internal communication and be a real manager of the team
· Ensure good communication between Laboratory and other departments
Management
· Improve the process, the organization of work and safety continuously
· Reach the objectives set out in the Annual Management Review Meeting
· Use the internal and external benchmark (= learn from others)
· Develop statistics, extrapolations and estimates along with the General Manager, analyze and customize
· Organize the sorting and archiving of the documentation from the laboratory
· Create the necessary in the laboratory work instructions and procedures
· Participation in the management meetings, management review meetings, review meetings and Facility Audits
Head of quality control
· Approval or, if it considers it necessary, rejection of raw materials & packaging materials
· Evaluation of batch reports
· Ensuring that all necessary tests/checks are carried out
· Approval of specifications, test methods and other quality control procedures (related to the lab)
· Approval of the external contract laboratories, as well as their monitoring
· Control of maintenance of the premises and the equipment of the laboratory
· Ensuring that the necessary validations will be performed
· Ensuring that the required initial and continuing training of staff of the laboratory was carried out and will
be adjusted to the respective requirements
The overall tasks of the quality control department, to the identification, validation and execution of all quality
control procedures, storage, ensuring proper labeling of containers containing the materials and products,
cooperation in the investigation of complaints in terms of product quality, etc. All these operations should be in
accordance with written procedures carried out and, if necessary, be documented.
Occupational health and safety
With the role of the Laboratory Manager, the management transfers the following duties in occupational health and
safety
· to control the execution of tasks
· to plan, carry out and update the risk assessment, including identification of hazards, evaluation of
risks and measures to reduce risks
· to control the effectiveness of the measures taken
· to prepare operating instructions in accordance with the risk assessments
· instruct new employees on general and company-specific hazards
· To plan, carry out and document the annual instructions/training of subordinate employees in
occupational health and safety
· Planning and carrying out occupational medical check-ups in consultation with the Human Resources
Department
· Ensure inspections of work equipment and facilities and their documentation in a timely manner
· cooperate with special functionaries such as the company physician and the occupational safety
specialist
· communicate occupational safety
· take health and safety into account during planning and procurement
· involve and inform external firms
· integrate temporary employees
· Ensure first aid and emergency response (including designation and training of first aiders in the
department)
. to appoint a safety officer for their department
Authority:
· represents the work in all matters pertaining to the laboratory
· reports directly to the General Manager
· dotted Line to Lab Operations Director
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
Skills:
· Leadership skills
· Technical credibility
· Organizational skills
· Efficient and accurate operation
· Flexibility
· Ability of problem solving
· Manager in the group
· Quality awareness
· Very good knowledge of English (written and spoken)
· Very good knowledge of MS Office