DSP Senior Specialist (Production Experts Team)

Participation in manufacture of biotechnology products in accordance with cGMP principles and FDA and other regulatory agencies requirements to obtain a product of specified quality in the specification. Improving and optimizing production processes by proposing changes and implementing solutions in cooperation with other departments and other plants of the Polpharma Biologics group. Participation in technology transfer in accordance with the legal  regulations and internal SOPs and in the implementation of projects related to the introduction of new biotechnology products. Participation in process validation and  qualification of the equipment and systems.

• Supervision and monitoring of the production process of biotechnological products in accordance with the principles of GMP, technological documentation and other internal requirements.
• Planning and initiating activities regarding production processes optimization.
• Supervision and monitoring of the technological trials in accordance with the principles of GMP, technological documentation and other internal requirements.
• Participation in the technology transfer in terms of implementing manufacturing processes of active substance in the production area.
• Participation in monitoring and continuous verification of the active substance manufacturing process.
• Review key documents & coordinate input for relevant registration documents for correctness & completeness (as appropriate).
• Documentation preparation and processing according GMP rules and internal company requirements.
• Participation as SME or owner in investigation for deviations, processing change controls, risk assessments and CAPA implementation.
• Participation in preparations and participation in external, internal, clients audits /  inspections.
• Actual delivering supervision or proper people reports and all necessary documentation to process evaluation.
• Informing direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions.
• Reporting the work progress and tasks status to supervisor.
• Development and verification of design documentation, systems and equipment qualification documentation and process validation documentation.
• Participation in the qualification of the equipment and systems and in the process validation. 
• Developing of the SOPs and operating instructions (including manuals).
• Close cooperation with the MSAT, Production Operational Departments, Engineering and Quality Departments and others and project teams.
• Work organizing and cooperation with others in order to make the most effective use of working time and timely completion of the tasks.
• Execution of the Tasks assigned by the superior.
• Conducting and / or supervising trainings (including developed documents) for employees of the Production Departments, MSAT, Engineering and Quality Departments and others.
• Participation in trainings.

• Higher directional education.
• Experience in working with recombinant proteins in the production scale or in thepharmaceutical industry.
• Knowledge  of protein chemistry and related with that interactions.
• Knowledge of techniques for the purification of recombinant proteins in the production scale.
• Experience in process validation and equipment, systems qualification.
• Experience in processing production and design documentation.
• Good knowledge of cGMP and FDA requirements for  biological and sterile products.
• Good speaking and writing English skills.
• Skills in good work organization, individual problem solving, good communication, team work and being open for new tasks are required.

• Competitive salary.
• Private healthcare.
• Life insurance.
• Pension plan above national standards.
• Relocation package.
• Additional free day.
• and more...