Quality Assurance Specialist

You will be a part of Distribution & In-market Quality Team responsible for activities related to Good Distribution Practice (GDP), license maintenance and local batch release process for Russian market, quality support for CIS markets

Main responsibility:

• Assure compliance with established Company’s policies/procedures and comply with all applicable governmental regulations (GMP, GDP, local legislation, etc.)
• Maintain the local Quality Management System
• Participation in Audits and Self-inspections
• Ensure Quality training of personnel including assessment of training effectiveness
• Complete trainings as required for role
• Handling of product quality complaints (PQCs)
• Participation in deviation management, overview and tracking, handling of temperature excursions during transportation, warehousing and distribution
• Participation in CAPA management, including tracking
• Participation in local recall coordination and execution
• Local batch release (routine and one batch per year) – AIS RZN, release in SAP
• Collaboration with laboratories
• Coordination of product testing between manufacturing site and CIS state laboratories, including management of any resultant investigations or queries
• Quality Agreements with providers and KPIs monitoring
• Product Quality Reviews

Qualification

Education:

• University Degree in a relevant science (preferably BS Pharmacy, Chemistry, Chemical Engineering, Biology (or equivalent) education)
• Basic knowledge of normative documentation, medicines state registration process, local pharmacopeia articles
• Basic knowledge of quality confirmation/local certification
• Experience and knowledge in the field of logistics (importation, customs clearance, warehousing, transportation including cold chain)
• Experience in the field of GMP/GDP and other applicable local legislation is preferable

Skills Required:

• At least 2 years’ experience in the pharmaceutical industry preferably with knowledge of Quality Systems, Quality Assurance and Quality Control including basic knowledge of global GMP/GDP and regulatory requirements.
• Strong compliance mind-set, motivation, communication and negotiation, multi-task.
• Some level of contractual and financial awareness is preferred.
• Excel spreadsheets, SAP, ETQ
• English (at least intermediate)