Localization/Regulatory Project Manager

з/п не указана

Вакансия в архиве

Работодатель, вероятно, уже нашел нужного кандидата и больше не принимает отклики на эту вакансию

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Требуемый опыт работы: 3–6 лет

Полная занятость, полный день

Job Purpose:

Person will work across divisions’ borders and ensure timely information and tasks delivery. Coordinator will work in a close collaboration with QA, Customs, Regulatory, EHS and Supply Chain divisions both in Russia and abroad.

Major Accountabilities:

  • Independently manage sample coordination at external partners, which may include batch shipments, QC sampling, QA retentions, Control samples, testing activities at various partner and MSD sites, triaging results and release decisions, communication of sample status as per Regulatory and Customs requirements during transit, and coordinate requisite activities with MSD QA, QC, EHS, Regulatory and other groups.
  • Provide appropriate input into the TQA and translations to adapt the TQA according to local Russian regulatory requirements
  • Ensure Quality requirements are communicated to external partners, and monitor as needed in partnership with MSD Global QA
  • Collaborate and work with MSD QA/QC and EHS Global functions for matters related to external partner management
  • Work together with Customs clearance and Supply Chain divisions on matters, related to products/samples/materials shipping
  • Support QA/EHS audits and associated monitoring activities at MSD’s partners, that will be run by MSD’s divisional QA or EHS auditors
  • Order all Toll materials from MSD EU site
  • Establish effective model for shipping/tracking samples for testing, analyzing CoA data
  • Support monitoring activities as it relates to MSD partner’s performance in line with MSD External Manufacturing standards
  • Manage QA release transactions in SAP as needed in collaboration with MSD Global QA.
  • Work with VGNKI on routine testing matters
  • Develop and implement release procedures (in line with the recent regulatory requirements)
  • Work with regulatory on MAs timely changes and updates
  • develop and implement procedures for the release of all incoming series into circulation in the Russian Federation

Requirements to the candidate:

  • Understand Vet regulatory and QA landscape and requirements in Russia
  • Previous experience in Pharma or Vet industry
  • Have basic knowledge of project management
  • Excellent analytical, problem solving skills
  • Have excellent communication skills and relations building capabilities
  • Fluent English

At least 5 years’ experience in the pharmaceutical industry at the manufactory

Вакансия опубликована 7 августа 2019 в Москве

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