American pharmaceutical company Elanco is looking for a Project Leader EEM Russia.
Key Objectives/Deliverables:
Translate and communicate between Russian Manufacturing Partners and the English speaking Elanco Corporate & Elanco European Contract Manufacturing Team.
Participate in manufacturing sourcing assessments and due diligence visits.
Support product technical transfers, change controls and support technical investigations.
Build a relationship with the Russian Manufacturing Partners and the English speaking Elanco Corporate & Elanco European Contract Manufacturing Team.
Provide support for the oversight of manufacturing procedures, batch records, specifications, changes and technical reports day to day operations (SOP, Batch Records).
Participate in regular site visits to the CM, to assess ongoing capability and, as required, to support resolution of complex technical issues and/or support implementation of significant process or procedural changes.
Play a proactive role in the implementation of projects, including capital projects, with respect to planning, documentation, commissioning, training, and process/cleaning validation. Ensure appropriate governance is in place for changes, through use of the current change management processes.
Originate change controls and events to support manufacturing changes that effect operations at Contract Manufactures (CMs) and Elanco sites as needed.
Support the process qualification and validation of equipment on Russian projects that evaluates the new or modified processes and/or components at CMs and internal Elanco sites.
Provide guidance regarding technical protocols and reports associated qualifications and/or validations.
Support the Audit group in auditing of Russian CMs.
Basic Requirements:
Fluent in Russian and English to be able to support technical discussions and document translations.
Expertise in Manufacturing or Manufacturing Quality environment ideally in veterinary pharmaceuticals and Feed Additives.
Expertise and knowledge of Russian regulatory and legislation requirements in area of veterinary pharmaceuticals, feed additives, manufacturing, registration and distribution.
Experience with process qualification and validation across pharmaceutical platforms (parenteral and premixes being the main ones).
Strong problem solving capabilities including strategic and creative thinking.
Strong interpersonal/communication skill: verbal and written.
Excellent project management skills — ability to support projects with contract manufacturing organizations.
Cross-functional networking and influencing ability.
Ability to handle multiple priorities and deal with ambiguity.
Thorough understanding of cGMP regulations and regulatory agencies packaging requirements from (country relevant Pharmacopeias).
Self-motivated Demonstrated strong documentation skills.
Demonstrated strong oral and written communication and interpersonal interaction skills.
