Position Overview & Specifications
Overview:
We are looking for an experienced Quality Operations Specialist to join our QA team here at hVIVO. The role is to be responsible for the management of QMS Documents, provide quality advice and support in relation to Policies, SOPs, and Master Forms as well as the management for eQMS (electronic quality document management system) system.
Additionally, the role is responsible for leading and having oversight of the Management of the Regulatory Archives (Paper and Electronic) across all hVIVO sites to ensure compliance with regulatory standards and guidelines.
Main Responsibilities: The main responsibilities for this role are;
Additionally, the role is responsible for leading and having oversight of the Management of the Regulatory Archives (Paper and Electronic) across all hVIVO sites to ensure compliance with regulatory standards and guidelines.
Main Responsibilities: The main responsibilities for this role are;
- Nominated Company Archivist, Oversight of management of the Archive;
- System Owner for eArchive system;
- Implement the Regulatory Archiving strategy;
- Monitor and analyse regulations and guidance related to regulatory archiving and implement changes to hVIVO procedures;
- Act as a source of advice and guidance on QMS document such as SOPs, policies and archive related quality issues;
- Day to day running of the eQMS system with support from QA associate(s) where company Policies, Standard Operating Procedures, and Master Forms, etc and CAPAs are managed;
- Implement processes for efficient creation, review and approval of documents within the eQMS systems.
- Training Operations on eQMS, SOP management and Archiving
- Provide assistance / support with Regulatory Training
- Support QA team with external client audits and Inspections
- Oversee the management and implement continual process improvement of hVIVO systems
- Lead cross functional and interdivisional/ departmental projects to improve compliance and quality
Demonstrated experience of working in a GCP/GCLP QA environment- Experience in all aspects of regulatory archiving in a CRO or pharmaceutical environnment
- Experience of managing multi-site archives
- Demonstrated experience of SOP management of clinical trials
- Ability to work with all levels of stakeholders in the business
- Degree or equivalent in science or relevant subject/experience
- Ability to take initiative and focus on deliverying robust customer service out to the business.