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Job Details

Quality Documentation & Training Administration

Company: Hobson Prior
Location: Cambridgeshire
Reference: CWi
Closing Date: 27 Dec 18
Type: Contract
Salary (£): On Application
Benefits: Up to £170 / day (£44k)

Job Summary:

Quality Documentation and Training Administration (QDTA) is an operational function within R&D Quality & Compliance. QDTA support our organisation’s enterprise wide compliance with Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPvP), Good Laboratory Practices (GLP) and associated regulations through provision of high quality support and service in administering and maintaining the Global Quality Management System (QMS).

Requirements:

Key activities include the collection, quality control, approval routing, reporting, and management of critical documentation and data, and serving as a subject matter expert for the use of tools and systems that support these activities.

Quality Documentation and Training Administration - Cambridgeshire

Job Responsibilities 

  • Routine interactions and collaborations will typically include internal hiring managers, new hires, procedural document/training content owners, learning & development professionals from diverse cross functional and worldwide locations 
  • Supports operational aspects of the QMS as follows, 
  • Processes and triages content from the central department mailbox. 
  • Responds to customer inquiries/requests with support from a more senior professional.
  • Follows formal Quality Control procedures, assuring consistent high quality output is maintained. 
  • Maintains departmental spreadsheet(s) with up to date reference information. 
  • Archives and maintains quality records and correspondence. 
  • Contribute to generation of workload and quality metrics/reports and assists with distribution. 
  • Provides quality oversight through review and analysis of records/data for compliance and consistency with procedural and regulatory standards. 
  • May under supervision of a more senior professional assist with system/process improvement initiatives. 
  • May provide operational support during audits and regulatory agency inspections. 
  • May assist with delivery of system/process training. 

Training Administration: 

  • Administrates user privileges in validated Learning Management System (LMS). 
  • Enters content and associated metadata into (LMS). 
  • Assigns training credit to learners. 
  • Creates and assigns applicable training curricula to users. 

Document Control: 

  • Enters content and associated metadata into the electronic Document Management System (eDMS) 
  • Performs data integrity focused quality checks on documentation 
  • Enters documents into approval workflows following dedicated procedures 

Key Differentiating Contributions: 

  • Work is performed under supervision using well defined procedures and detailed instruction 
  • Contributes to aspects of interdepartmental projects 

Key Skills 

  • Strong attention to detail and ability to consistently meet high standards of quality required in a GxP environment. 
  • Systematic in obtaining and using information. 
  • Systematic in assuring the accuracy/quality of their own work. 
  • Capable of performing regular routine work tasks to a consistent high standard of reproducibility. 
  • Good understanding of formal business structure and organizational awareness. 
  • Good verbal, written, interpersonal communication and organizational skills. 
  • Good knowledge of Microsoft office programs eg Word and Excel. 

Requirements

  • BS or BA degree with no experience or 2+ years of relevant experience in absence of formal qualification. 
  • Experience working in a regulated or GxP environment is desirable. 
  • Familiarity with/use of validated document management and learning management system software, and applications eg Documentum, Veeva Vault, UL Compliance Wire is desirable. 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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