АО "ВЕРТЕКС"

Advanced sourcing of API, excipients, packaging for generics, food supplements and cosmetics production (150+ SKU, 60+ suppliers around the world). Processing of alternative sources. 
Sourcing and Audit of contract manufacturing sites for particular stages of drug manufacturing process.
Building mutually beneficial long-term relationships with partners.
Project management (work within strict timelines under strong regulatory compliance,  50+ projects at a time).
Control of quality requirements (USP, EP), GXP compliance, test production and methods agreement. 
Collaboration with R&D division, RA, QA, QC departments.
Contracts management, processing of orders, accounting document workflow.
Networking, suppliers negotiations.

Senior Procurement Manager

Planning and control of GxP education system for Pharmaceutical plant employees (40+ trainings for different groups of specialists, 1400 employees), work with e-learning system.
Planning, implementation, control of GxP documentation system' work (400+ SOPs). Writing and control of SOPs. 
Data integrity system implementation.
Internal audits of WERTEX divisions.
Supplier auditing.
CAPA system management.
Scheduled quality meetings with quality related divisions at regular basis.
Participation in WERTEX external auditing (3rd parties).

GxP Education and Business processes reglamentation lead

Quality management system implementation and successful certification (GMP, GDP, GVP, ISO 9001, ISO 22000) under the control of Quality Management Director.
Licensing (pharmaceutical manufacturing).
GxP processes implementation and description.
Documentation and records management.
GxP education.
Change management.
CAPA & Deviation management.
Risk analysis.
Validation control.
Internal audits.
Supplier audits.
Planning, Budgeting and Control of department work (8 people).
500+ GxP documents created&reviewed.
1000+ CAPAs implemented.
200+ audits completed.

Head of quality management department

GxP documentation (SOP, URS, Quality Specifications) .
Batch records control.
Internal audits.
GMP & GDP deviation investigations.
Supplier qualification (100+ suppliers).
Suppliers quality claims management.
WERTEKS Claims management (customers and health authorities).
Product recalls management.
Qualification (2 production units).

Lead Quality Assurance Engineer

Severnaya Zvezda (pharmaceutical manufacturing)

Routine quality control tests (raw materials, API, finished product): pH, spectrophotometry, IR, titrymetry. 
Documentation preparation.
Batch records control.
Stability studies & samples management.
Reagents management.

Quality Control Chemist

Procurement manager (pharma/ cosmetics/ food supplements' components) with a strong Quality Management background.  Industrial manufacturing fan. 
Never-ending professional сuriosity,  optimism and interest in people.

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