Quality Documentation Specialist
ProClinical is working with a major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Quality Documentation Specialist to join their West London team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.
This Quality Documentation Specialist will support the company Document Management System, including the uploading, routing, reviewing, approving, issuing and obsoleting of quality documents. To provide training and user support to all company users of the document management system.
Role and Responsibilities:
- Affiliate Document Management System (DMS)
- Act as administrator and super user of the electronic DMS
- Support subject matter experts with the management of documentation in the electronic DMS
- Ensure documentation complies with established company electronic documentation system standards and document management policies
- Provide timely and efficient support to the documentation system users in handling document workflows and document change request
- Monitor progress of documents in workflows, ensure timely follow up and completion
- Proactively manage the quality documents periodic review process Archive management
- Ensure documentation and records are archived and retained in compliance with company policies
- Provide support and guidance regarding general document management and records archiving process QMS training
- In coordination with the Quality and Compliance Training Manager ensure appropriate document management system training is delivered and recorded for relevant personnel in the affiliate and relevant third parties.
- Support employee on-boarding by providing new hire training on the document management system Monitoring and audit/inspection readiness
- Provide support for internal/external audits/inspections for the UK/Ireland Affiliate in relation to the document management system
- Report relevant document management system metrics to affiliate management team and other relevant internal stakeholders Internal Affiliate Development (Culture)
- Work with the Quality team to continuously educate the affiliate on the importance of quality management and facilitate implementation of best practices
- Identify process gaps and solutions by continual review of existing company compliance-related Quality processes (global, regional and local)
Skills and Requirements:
- Established knowledge of quality management principles and systems
- Excellent communication and collaboration skills
- Experience of delivering training and providing ongoing user support
- Solution orientated
- Highly organised and efficient
- Able to multi task whilst maintaining a very high level of accuracy and attention to detail
- Excellent written and verbal communication skills
- Experience of supporting audits and internal quality/compliance reviews
- Appreciation of the reputation of the industry and an understanding of how to protect the company's reputation
- Life science/pharmacy degree
- A professional qualification in Quality &/or auditing would be advantageous Core Leadership Competencies (Behaviours)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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