QC senior specialist / specialist (consumable materials) - Interim

• participating in the project related to the launch of a new laboratory at the plant on biotechnology and other projects implemented in Quality Control;
• verification of the correctness of test documentation in accordance with applicable procedures;
• writing specifications of raw materials and consumables;
• sampling analytical samples (raw materials, clean media);
• collection and registration of clean media, raw materials, for analytical testing;
• conducting documentation related to sampling and registration of samples;
• participation in the development of the GMP system in the Quality Control Laboratory;
• Conducting investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality;
• participation in the preparation of the Quality Control area for GMP audits and certification;
• working out of standard procedures, instructions and analytical methods as well as training in them.

• 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.

Supplementary information - contract for a fixed period of 18 months with the possibility of extension.