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)
