This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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
Job 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
Requirements:
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
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