Report To
QC Manager, Russia Operations as the line manager
Location
Russia, Kaluga Region, Vorsino
Role Purpose
• Participates in laboratories launch and implementation of QC laboratory systems (Empower, LIMS) and EERP system (SAP) on site
Key Accountabilities
• Participates in implementation of QC laboratory and EERP systems (URS customization, data migration) for Quality control procedures (member of the Empower, LIMS, SAP implementation team).
• Participates in laboratories launch, instruments installation and qualification/validation.
• Develops SOPs and APs and other documents related to laboratory operations, equipment maintenance and analyses.
• Participates in the transfers of analytical methods analysis of AstraZeneca Products in the AZ Industries laboratory
• Develops specifications for laboratory equipment, products and materials
Qualifications
• University Degree (Pharmaceutical or Chemical or Biological)
• Good written and spoken English and Russian
• A minimum of 2 years of relevant professional experience as a analyst in a pharmaceutical manufacturing company
• Sufficient experience in physicochemical methods of testing: HPLC, GC, IR-spectroscopy, spectrophotometry, polarimetry
• Knowledge of basic laboratory equipment used in medicines control
• Knowledge of State Pharmacopoeia (GF XI, XII), European Pharmacopoeia (Eur.Ph)
• Knowledge of QC laboratory systems (Empower, LIMS, SAP).
• Advanced PC user
• Willingness to work 80 km to South-West of Moscow Region
• Open-minded and positive attitude
The above descriptions are intended to describe the general nature and level of work being performed, it is not intended to be an exhaustive list of all duties, responsibilities and skills required. Incumbent may perform other duties as assigned.
