Responsible for the Clinical Quality Assurance functions of the company reporting to the Executive Manager. Ensuring planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies/projects conducted.
Lead a team focusing on continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the local regulations. This involves working closely with department team and, and other related departments to help ensure active participation in continuous quality improvement activities.
Opportunities in Quality:
- Developing and establishing a company's quality procedures (SOPs), standards and specifications. Setting standards for quality level while working with biological samples as well as health and safety of the staff involved;
- Comply with all regulatory requirements, company operating procedures and other methodologies;
- Making sure that product quality level meet international and national standards and special customer requirements;
- Reviewing customer requirements and making sure they are met;
- Monitoring team performance by gathering relevant data and producing statistical reports, interaction with related departments.
Essential Duties and Responsibilities of the quality department:
- Working with human biological samples:
- Permanent quality check of the biological samples meeting customer requirements, internal/external regulations;
- Ensure biological samples are stored in a proper conditions meeting safety requirements. Develop clear logic of the biological samples storing and correlating with data base system;
- Development, implementation and control of all required SOPs as basic guidance tool for the department staff;
- Regular analysis of the product quality level, interaction with departments, improving results;
CRM system/ Quality profile:
- Ensure proper medical data entry, meeting terms and internal/external requirements;
- Making sure all medical printed files are stored in a proper way. Storage arrangement with clear logic;
- Development, implementation and control of all required SOPs as basic guidance tool for the department staff.
- Development of close relations with the logistics partners;
- Ensure company use best packing and shipping solutions for the biological samples (export/import);
- Clear understanding of all required logistic regulations while working with biological samples.
Certification/ SOPs/other regulations
- Achieve Quality compliance with international standards while working with human biological samples;
- Develop and Implement all required SOPs/instructions ensuring quality standards are met;
- Receiving appropriate certification as the final goal
- Experienced in similar field, desirable in medical sphere;
- Fluent spoken and written English;
- Excelent organization and communication skills;
- Solution-oriented and a good team player;
- Ability to travel (by land and air), both domestically and internationally, on occasion.