Quality Assurance Specialist

Development, verification, revision, and improvement of pharmaceutical quality system (PQS) standard operating procedures, implementation of relevant processes; Verification of validation/qualification documentation (URS, FMEA, DQ, IQ, OQ, PQ, etc.) for compliance with internal company requirements and EAEU and EU GMP requirements; Organization of the process for drafting, issuing, withdrawing, and storing pharmaceutical quality system documents, and maintaining their records; Control of SOP implementation in the company: conducting GAP analysis of corporate and local company procedures, preparing reports on the volume, quality, and deadlines of developed company SOPs and instructions; Participation in the implementation of electronic systems supporting PQS processes; Maintaining documentation on training company employees within the PQS framework: planning internal training, developing materials for initial and periodic employee training, maintaining documentation in accordance with the established training procedure, optimization and improvement of the training process; Tracking changes in legislative requirements, as well as internal corporate policies and company SOPs, developing action plans for changes, and monitoring their execution; Participation in risk analysis and assessment processes.

Requirements

Higher education: Bachelor's, Specialist (pharmaceutical, chemical, biological, biotechnological, technological, medical, etc.); At least 5 years of experience in quality control or quality assurance in a pharmaceutical company with a Bachelor's degree; At least 3 years of experience in quality control or quality assurance in a pharmaceutical company with a Specialist degree; Proficiency in written and spoken English at an upper-intermediate level; Ability to work in core MS Office applications (Word, Excel, PowerPoint, Visio); Knowledge of EAEU and EU GMP Rules and EAEU recommendations; Ability to work independently and in a team; Experience in quality assurance, equipment qualification, and computerized systems; Analytical thinking, responsibility, honesty, flexibility, openness, ability to work with large volumes of information; Possibility of relocation; Knowledge of medicinal product manufacturing processes.

Higher education — Bachelor's; Experience: 3 years

Conditions

Permissible