Production Specialist (Fractionation Department)

1) Study of "OCTAPHARMA" production processes (internship at other "OCTAPHARMA" production sites); 2) Support for project activities related to the department's activities, according to the project schedule: approval of project documentation (User Requirement Specifications (URS), layouts, P&ID, technical and functional specifications), proposing ideas for optimization and improvement; 3) Support for equipment acceptance and qualification processes: participation in FAT, SAT, IQ, OQ, and PQ, approval of protocols and reports; 4) Continuous deepening of knowledge and expertise in fractionation processes and equipment; 5) Implementation of "OCTAPHARMA" production processes at the new plant in full compliance with GMP requirements; 6) Development and maintenance of up-to-date technological documentation; 7) Support in conducting technology transfer for "OCTAPHARMA" products; 8) Development and approval of SOPs, work instructions, and completed forms related to the department's activities; 9) Training production personnel on equipment operation and production methods in accordance with GMP requirements; 10) Monitoring production operations for compliance with technological instructions, production recipes, safety instructions, SOPs, and GMP requirements.

Requirements

Higher education in natural sciences, preferably in chemistry, biology, pharmacy, biotechnology, pharmaceutical, or chemical technology. At least 2 years of experience in GMP and production; preferably in the pharmaceutical industry. Experience with tank equipment, pressure vessels, and industrial chromatography will be an advantage. Special requirements for the candidate: Intermediate level of English (level B1 and above). Knowledge of EU GMP and EAEU GMP requirements and guidelines.

Higher education — Bachelor's degree; Experience: 1 year