Ekaterina Sidorenko

Experience

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  JSC Borisov Plant of Medical Preparations

  Aug 2015 - Aug 2017

  Engineer Technologist

  · Developed GMP documentations (Technological instruction and SOPs)· Lead CAPA (Update of SOP’s, organization of system of monitoring of particles in zone A and personnel training etc) development activities jointly with QA· Managed data preparation and optimization, cleaning validation, process validation, and control validation jointly with the QA · Managed the projects related to technology transfers (Workshop of sterile powder packaging antibiotics)· Ensured that protocols of validation were followed and filled out· Trained, advised, and educated new personnel and other staff about various complex procedures and problems· Participated in SAT, IQ, OQ, and PQ· Led the risk assessment group Show less

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  NatiVita

  May 2017 - Aug 2018

  Technologist

  · Took charge of the development and start of new lines of cytostatics and cytotoxics production· Developed GMP documentation· Provided guidance and training for junior operators· Maintained areas and manufacturing documentation in compliance with SOPs and cGMPs.· Helped in identifying continuous improvement and cost savings opportunities· Participated in SAT for equipment line (include System of preparation and filtration solution for injections, line of filling machine, machine mixer granulator, fluid bed drier etc)· Negotiated the qualification of equipment with foreign partner such as Nicomac, Truking, Sartorius· Visited site of Sending Unit NATCO Pharma Limited (India) for estimate critical stages and implemented the process on Receiving Unit (NatiVita) Show less

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  Valenta Pharmaceuticals

  Aug 2018 - Mar 2020

  Quality Assurance specialist

  · Conducting a GMP Supplier Audit· Risk assessment· Responsible for writing, executing & reporting of all validation activities including but not limited to (VP/ DQ / FAT / IQ / OQ / PQ / Deviations).· Process qualification including all areas of the validation life cycle.· Responsible for planning and coordinating validation schedules on site· Responsible for all associated validation documentation compliant with GMP.· Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.· Resolve and assist in the closure of deviations initiated during qualification / validation execution. Show less

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  Astellas Pharma

  Apr 2020 - May 2021

  Contract Manufacturing Manager

  - Coordination and control of the realization contract manufacturing of transfer technology analytical methods and technology- Managements of the projects during life cycles of the project (initiation of the projects, planning, executive, supporting and closing) - Participation in the negotiation , updated of the agreement with CMO- Management of Risk project- Audit of CMO- Coordination of work departments within company

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  Aspen Health

  May 2021 - Jun 2023

  Technology Transfer Manager

  - Supporting Technical Transfer activities - Communication with external CMO and other parties of project- Providing input, review, and approval technological and analytical activities -Leading cross-functional meeting - Coordination project plans and control timelines control

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  LLC Binnopharm group

  Jun 2023 - now

  Project manager