Quality Control Specialist

In this role, as a member of our growing Quality Control Preparation and Certification team you will take care of a broad scope of responsibilities within the highly regulated, but very dynamic laboratory environment. This position is an opportunity for you to become a valuable expert in the biopharmaceutical industry.

• Building of a pharmaceutical quality assurance system, qualification of control and measurement equipment, preparation for GMP certification - applicable to the design phase;
• Sampling analytical samples (raw materials, clean media);
• Registration, division and distribution of analytical samples;
• Conducting documentation related to sampling and registration of samples;
• Participation in implementation Laboratory Information Management System;
• Participation in developing or giving opinions on Instructions and Procedures;
• Participating in change control processes (e.g. by issuing opinions on new tests methods and specifications and their implementation in the team);
• Conducting samples archive;
• Monitoring environmental conditions.

• Higher education, with a specialization in the fields: biotechnology, biology, chemistry or related;
• Experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works, (at least 3 years);
• Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines;
• Readiness for shift work;
• Fluent English spoken and written;
• Organizational skills;
• Strong communication and presentation skills.