Quality Regulatory Services Administrator
Bridgend, United Kingdom
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
General Purpose of Role:
Perform administrative tasks to support the QRS function.
Main Responsibilities:
- Manage audit documents within the e-QMS (electronic quality management system)
- Create new GxP documents within e-QMS
- Maintain client supplied documents
- Update Supplier module with new entities
- Upload documents into audit module
- Track audits to closure
- Maintain schedule of required audits
- Manage documents through their electronic signature lifecycle.
- Assist staff with travel arrangements
- Manage and schedule new work into the QRS programme
- Manage monthly billing ensuring all completed work is billed for
- Ensure all expenses are complete and submitted for billing
- Other duties as required with job level
Desirable Qualifications
- NVQ/HND/HNC/Degree level educated (or equivalent)
Specific Knowledge / Skills Competence
- Advanced working knowledge of MS Word
- Good working knowledge of MS office packages (Excel, Visio, PowerPoint)
- Knowledge and experience working with Smartsheets
- Basic understanding of document control requirements
- Ability to write logical and coherent documentation
- Literacy skills
- Numeracy skills and ability to report financial information
- Excellent written and communication skills
- Administration of controlled documents
- Administration of document archiving systems
Desirable
- Knowledge of Quality Management Systems
- Understanding of EU GxP
Behavioural Competencies:
- Ability to work autonomously with minimal supervision
- Ability to prioritise individual workload in line with department goals and objectives
- Excellent written and verbal communication.
- Good attention to detail
Apply
Career Focus: Analyst, Quality, Regulatory
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