Main responsibilities
- Participation in the development, improvement and implementation of the validation (qualification) system at the enterprise
- Development and completion of regulatory and registration documentation for validation in accordance with GMP requirements
- Planning and execution of activities for the organization and conduct of qualification/validation
- Participation in qualification and validation works (validation of the cleaning process, technological process, qualification of technological equipment, engineering systems, production and storage facilities)
- Participation in projects for the selection of new equipment
- Preparing training presentations and conducting validation training for enterprise personnel
- Participation in internal audits as an internal auditor, as well as participation in external audits as an auditee
- Risk assessment and work with them
Our expectations
- Higher education (chemical/chemical technology/pharmaceutical)
- Work experience of at least 1 year in the field of validation at a pharmaceutical company
- Knowledge of Russian and European legislation in the field of production and quality control of medicines
- Knowledge of PIC/S, WHO, GAMP5, FDA CFR 21 part 11, ICH Q9 guidelines and recommendations
- Knowledge and understanding of drug production technology, the life cycle of computerized systems, the principles of operation of basic technological equipment and engineering systems (HVAC)
We offer
- Official competitive salary
- The prospect of career growth due to the personnel reserve program
- The VMI program
- Personal Birthday Award
- Power compensation
- Soft adaptation under the guidance of an experienced mentor
- Active corporate life
- Service delivery
Working hours
- 5/2 from 09.00 to 18.00
- 5/2 from 08.00 to 17.00
Place of work
- St. Petersburg, Pushkin, Avtomobilnaya St., 3B
Service shuttle from metro stations "Dunayskaya", "Kupchino"
