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Quality R&D Manager Documentation & Training

Quality R&D Manager Documentation & Training

Job Title: Quality R&D Manager Documentation & Training
Contract Type: Permanent
Location: Surrey
Industry:
Salary: £40000 - £50000 per annum
Start Date: ASAP
Reference: HQ00050784
Contact Name: Rachel Radford
Contact Email: r.radford@sciproglobal.com
Job Published: February 03, 2017 15:37

Job Description

Key responsibilities include but are not limited to:

  • Responsible for development, implementation and management of Document Management Systems/Processes for global CHR&D documents
  • Interface with CHRD, Quality, Supply Chain and NPI team to ensure the global documentation system is efficient and robust, and meets customer requirements
  • Responsible for issuing, tracking, storage and archive activities inclusive of data entry, customer requests, offsite records storage and records retention activities for UK sites
  • Provide support for legal activities in response to preservation or litigation notices
  • Liase with external companies - scanning, offsite storage, service contractors
  • Provide technical consultation and training for MyLearning, Document Management Systems, Record Management and other quality systems as required
  • Implement and manage corporate standards and policies (e.g. Retention Schedule) within CHR&D
  • Responsible for global CHR&D training program including the management of MyLearning training system for CHR&D staff
  • Provide guidance to CHR&D associates in developing on-line training modules for myLearning. Uploading and testing of on-line modules for myLearning

Key requirements:

  • Bachelor of Science Degree
  • Understanding of product technical specifications and GxP documentation utilised in product development
  • General knowledge of global regulatory requirements (e.g., US FDA, EMEA, ICH, Pharmacopeias, etc.)
  • Subject Matter Expert in the area of document management and/or training
  • Experience working in global and multidisciplinary environments
  • Experience with Computer System Validation
  • Familiarity with audit/quality systems (e.g., Trackwise) and regulatory submission management system

If you are interested in this role and you believe you would be a good fit, please don't hesitate to apply!

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