Job Description
Job Title – Document Controller
Location – Abingdon, Oxford
Contract Length – N/A – perm
Pay Rate – approx. 30k
Key Responsibilities:
* Ensure all CTEC-Oxford quality documents, including, but not limited to Work Instructions, Technical Documents and SOPs, are in the right templates are formatted correctly and align with EDMS whilst adhering to procedures for Document Control.
* Cross-check CTEC-Oxford documents with pre-existing quality documents.
* Provide document drafting, review and approval as part of equipment and software purchase and implementation.
* With the help of management and quality teams link quality work instructions to pre-existing SOPs.
* Ensure smooth day-day administrative operations at CTEC Oxford team, in compliance with policies and regulations.
* Take ownership of purchasing reagents, consumables, and equipment.
* Arrange and manage on-site leadership meetings and coordinate all associated accommodation, transport and catering.
* Review and optimize office policies and procedures٫ particularly documentation and filing systems.
Skills & Experience:
* Have experience with working in or with a quality management system, preferably to ISO 13485.
* Are adept at using and navigating large document repository databases.
* Having worked in/with Regulatory and Validation teams and QA would be beneficial.
* Having drafted User Requirement Specification, Validation Plans and be aware of IQ/OQ/PQ and 21 CFR Part 11 would be advantageous.
* Strong IT skills and knowledge of Microsoft Office Suite, principally, Word.
* Excellent organisational and time-management skills.
* Excellent record keeping skills.
* The ability to prioritise tasks and work under pressure.
* Strong attention to detail.
* Having basic lab experience would be an advantage.
* Strong collaboration skills and experience of working within a team.