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