Senior Quality Specialist
Responsibilities:
- Testing medicinal product batches for compliance with quality standards in accredited laboratories per Russian laws.
- Confirming compliance of the imported medicinal product with the requirements established during its state registration:
- assessment of conditions of the product transportation and storage.
- assessment of compliance of actual parameters specified in the product quality passport (quality certificate) with the specification parameters approved during registration of the medicinal product in the Russian Federation.
- organization and control of sampling medicinal products for assessment of compliance of products received with the specification parameters.
- execution and publication confirmations of the medicinal product batch compliance with the quality requirements established during its registration, on the website of Roszdravnadzor (Federal Service for Surveillance in Healthcare) before putting the batch into civil circulation.
- execution of other documents and notifications in authorized organizations (public and commercial) about putting a batch or lot into circulation in the Russian market.
- Assessment of data about deviations and scheduled changes in manufacture and (or) quality control in relation to the quality of the medicinal product released, including:
- initiation of CAPA plan for any deviations relating to product quality parameters.
- assessment of medicinal product batch dossier and annual quality review as needed.
- Supporting efficient management of Product Quality complaints.
- Organizing audit of service providers within the area of his (her) responsibility (i.e laboratories, reagent’s suppliers).
- Participation in the medicine recall process.
- Performing individual tasks and assignments issued by the line manager during the working process.
Core Competencies / Skills:
- Higher education in chemistry/chemistry and technology/chemistry and pharmacy/biology/biology and technology/microbiology/pharmacy.
- Experience of work in QA/QC more than 3 years.
- Advanced level English, including knowledge of specialized terminology.
- Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards.
- Experience of participation in audits (internal, external, including service providers).
- English – Upper-Intermediate (Spoken and written)Solid knowledge of EAEU GMP, GDP, requirements to the Quality Management Standards.
- Knowledge of requirements of 61st Federal Law about medicine’s circulation.
- Knowledge of requirements of international standards and recommendations on GMP quality processes (WHO, PIC/S, FDA).
- Experience of performing audits and inspections (internal, external, including service provid-ers).