The QA Controller will be responsible for ensuring documents and records are created, approved and maintained in accordance with company procedures and available at point of use. The role will also play a key role in establishing an electronic document management system as well as maintaining and refining the quality system in line with business needs.
This role is on a one year fixed term contract.
Knowledge & Experience:
- Minimum two years Document Control experience ideally in pharmaceutical, medical device or other related industries
- Working within an ISO 13485 Quality Management System under the Medical Devices Directive (MDD)/Medical - Devices Regulation (MDR) for product development and/or manufacturing in the UK/EU is desirable
- An HNC or degree in a related subject, or equivalent level of experience
- Competent in MS Office Suite and Windows applications e.g. Word, Outlook, SharePoint, Excel, PowerPoint, Visio etc
- Proficient in document formatting
- Experience of implementing an electronic documentation management system is desirable
- Excellent oral, written communication and interpersonal skills
- Attention to detail, commitment to Quality, accuracy, efficiency, and consistency
- Some exposure to regulatory agency inspections (e.g. FDA, notified bodies, etc.) is desirable
- Ability to work under limited supervision, manage multiple tasks and prioritise assignments within established time constraints
- A strong team player who is motivated by the success of the business
- A self-starter committed to making things happen
- Ensure documents are reviewed, approved and maintained in accordance with defined processes.
- Support in maintaining and continuously improving the quality management system in compliance with regulatory requirements
- Ensure documents remain legible and readily identifiable
- Prevent deterioration or loss of documents
- Prevent the unintended use of obsolete documents
- Support systems integration and deployment of electronic document management system
- Manage training records
- Support Audits, CAPA’s, Change Control, Deviations/Concessions, Root-Cause Analysis, and Complaint handling where required
- Maintain design change and equipment logs
- Monitor quality related KPI’s
- Monitor and control documents of external origin e.g. industry standards
- Make available, notify and distribute documents to relevant recipients
- Keep abreast of new developments in QA/RA e.g. standards and regulations
- Work closely with internal and external multi-disciplinary product development teams to ensure project success
- Deliver relevant training on the QMS to existing and new staff within remit of responsibilities
How to Apply:
If you believe you have what it takes to excel in this role, tell us why in a covering letter and CV.
Closing date for applications: Friday, 30th July 2021