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Quality Specialist

REED
Job LocationWelwyn Garden City
EducationNot Mentioned
Salary£40.00 - £50.00 per hour, inc benefits
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeTemporary, full-time

Job Description

My client is a leading Global Pharmaceutical Development Organisation recruiting for a Quality Specialist on Temporary contractualbasis in the first instance.Overview:

  • To implement the controlled document strategy for PDQ and the supported business partners for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.
  • To develop Global Procedural Documents, e.g., Policies, Standard Operating Procedures, Work Instructions from identification of needs, to execution of development and deployment of outputs and materials.
  • Demonstrated knowledge of GCP and/or GVP regulatory requirements, as well as analytical, organizational and planning skills.
  • Broad understanding of global expectations of Regulatory Authorities in the area of pharmaceutical development.
    • Primary Responsibilities:
  • Supports establishment of GxP Global Procedural Documents to ensure a consistent process landscape for standards, processes, procedures related to clinical development and safety/pharmacovigilance tostandards of regulatory compliance
  • Builds and maintains strong relationships
  • Identifies needs for process standardization, regulatory compliance direction and areas for improvement.
  • Ensures that business partner expectations for Procedural Document strategy, materials and deployment are met.
  • Ensuresthat Global Procedural Documents in the GxP process landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations.
  • Collaborates with a network of subject matter experts
  • Contributes to the PDQS Standards, Systems & Processes Governance Team
  • Is knowledgeable of all services and activities provided by PDQS, Standards, Systems and Processes Governance
    • Experience/Skills:
  • Experience developing multiple Procedural Documents simultaneously to high quality
  • In-depth knowledge of pharmaceutical development processes, including Quality Management Systems, and relevant GxP regulations.
  • Strong interpersonal and stakeholder management skills
  • Ability to build and maintain good relationships
  • Problem identification and resolution
  • Analyse and simplify complex systems or processes
  • Ability to assimilate new and emerging compliance information or trends.
  • Computer proficiency, including Microsoft applications, Adobe Acrobat, and Documentum (or similar).
  • Manage cross-functional and interdisciplinary teams and projects
    • Education/Qualifications
  • Degree or equivalent in scientific or quality-related field or equivalent
  • 3-5 years in the pharmaceutical industry
  • Experience in preparation, development and administration of GxP standards and processes.
  • Organizational awareness (e.g., interrelationship of departments, business priorities), including experience successfully working cross-functionally and in global teams.

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