Qualification and Validation Specialist

Development and implementation of procedures for the qualification (validation) of production systems (cleanrooms, clean environments, equipment, computerized systems, etc.) and processes in accordance with GMP requirements; Development of the strategy (approaches) for conducting qualification (validation); Conducting impact assessments (SIA) and risk analysis (FMEA) to determine qualification (validation) objects and the scope of their testing; Development of qualification (validation) documents: URS, plans, protocols, reports; Planning and execution of qualification (validation) tests: DQ, IQ, OQ, PQ; Participation in FAT and SAT activities, including documentation review; Monitoring of validated (qualified) GxP objects; Conducting impact assessments of changes on the qualification (validation) status of GxP objects; Conducting significance assessments of deviations identified during qualification (validation) testing and organizing their investigation.

Requirements

Higher education (pharmaceutical, chemical, biotechnological, technical); At least 2 years of experience in pharmaceutical production and/or in the field of qualification (validation); Proficiency in spoken and written English at no lower than Intermediate / Pre-intermediate level; Ability to work in MS Office programs (Word, Excel, PowerPoint); Knowledge of qualification (validation) testing methodologies and basic statistical analysis methods; Skills in handling control and measuring equipment; Knowledge of Good Manufacturing Practice GMP requirements (RF, EAEU, EU) and industry methodological and guidance documents (ICH, ISPE, PDA, PIC/S, etc.) in the field of qualification (validation). Responsibility, result orientation, communication skills, teamwork, attention to detail.

Higher education — Bachelor's degree; Experience: 3 years