Senior Manager, GxP Controlled Document Management (m/f/d)

at  Otsuka Pharma

Frankfurt am Main, Hessen, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate29 Dec, 2024Not Specified01 Oct, 2024N/AGood communication skillsNoNo
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Description:

JOBBESCHREIBUNG

  • Management and administration of the global GxP Policies, Standard Operating Procedures (SOPs) and Working Practices (WPs)
  • Cover GxP documents related to Medical Affairs, Regulatory Affairs, IT, and others if needed
  • Independently coordinate the development and revision of these documents, following the Global Procedure for document management
  • Create project plan and maintain timelines, drive revisions to completion
  • Provide oversight and guidance for Key Stakeholders of SOPs
  • Maintain current records in the electronic Document Management System (eDMS)
  • Liaise with the Global Training Group
  • Support the management of deviations and CAPAs related to GxP Document Management
  • Participate in internal improvement projects, lead projects as assigned
    This position is to be filled as a parental leave replacement for a limited period from December 1, 2024 to November 30, 2025.

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Frankfurt am Main, Germany