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QA Document Administrator

Job Description:

Job Title: QA Document Administrator
Location: Bridgend
Department: Quality Assurance (QA)
Work Pattern: 40 hours per week
Reporting to: Senior QA Officer
Responsible for (staff): N/A

As a QA Document Administrator you will maintain controlled documentation within the company’s electronic document management system and provide general administrative support to the QA Department.

Essential Duties and Responsibilities:

  • Manage documents within the e-QMS
  • Create new GxP documents within e-QMS
  • Track and facilitate document change requests
  • Communicate document review requirements to department managers
  • Produce monthly document status reports
  • Control the issue, distribution and withdrawal of e-documents
  • Issue documents for training
  • Write and author Standard Operating Procedures and instructional documents within scope of duties
  • Coordinate scanning and archiving of hardcopy documents
  • Manage QA/QP and Client audit calendars
  • Support client audit arrangements (as required)
  • Administration of batch records for QP review
  • General administration tasks (e.g. Travel arrangements, completion of purchase orders, meeting minutes etc.)
  • Assist with GMP software validation as required
  • Other duties as required with job level

Requirements:

Regulatory/Industry Responsibilities:

General

  • Advanced working knowledge of MS Word
  • Good working knowledge of MS office packages (Excel, Visio, PowerPoint)
  • Basic understanding of document control requirements
  • Ability to write logical and coherent documentation
  • Basic literacy and numeracy skills
  • Excellent written and verbal communication skills
  • Administration of controlled documents
  • Administration of document archiving systems
  • Experience of working in an administrative role
  • Experience of working in a document management role
  • Ability to work autonomously with minimal supervision
  • Ability to prioritize individual workload in line with department goals and objectives
  • Attention to detail

Preferred

  • Knowledge of Quality Management Systems
  • Basic understanding of EU GxP
  • Experience of working in a GxP regulated environment.

Qualifications:

Required

  • GCSE Grade C and above in English and Mathematics (or equivalent)

Preferred

  • NVQ/HND/HNC/Degree level educated (or equivalent)
  • Basic IT Qualification e.g. Clair, EDCL or equivalent

Please fill in the form to apply

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