I’m partnered with a Large Pharmaceutical organisation based in Cambridge. They are looking for a Quality Documents and Training Administrator with the following skills to join their team for a 12 Month Contract.
Quality Documents and Training Administration support the organisation’s enterprise wide compliance with ICH GCP, GPvP and associated regulations through provision of high-quality support and service in administering and maintaining the Global Quality Management System.
- Support the Global Document Management and Training Administration programs:
- Administrates the electronic Document Management System (eDMS) and Learning Management System (LMS) including managing user accounts, assigning access rights and initiating workflows
- Administrates Procedural Documents and Quality records through the eDMS, including the change management, electronic review/approval, periodic review and obsoletion workflows
- Enters data into the eDMS and LMS
- Performs quality control of entered data and follows appropriate procedures to ensure the quality of information contained in the eDMS and LMS with global quality standards
- Serves as functional liaison with local Procedural Document and training coordinators at International affiliate locations
- Addresses and resolves customer questions promptly, maintains close cooperation and communication with international affiliate personnel
- Ensures consistent application of systems and process to ensure the quality of their work, and the high standards expected in Compliance
- Supports the creation and implementation of globally standardized processes applicable to the quality management system and their deployment to headquarter and affiliate locations
- Provides support in regulatory agency inspections. May coordinate audit follow-up and corrective action planning with appropriate functional areas
4+ years of relevant experience with a BS or BA degree (or 3+ years with a Master’s degree) in a relevant field, such as a Quality Control, Quality Assurance, Regulatory Operations or similar GxP/Regulated environments.
Experience with eDMS eg Veeva Vault, MasterControl, Documentum is highly desirable
- Must have experience managing content in an eDMS or LMS
- Must be proficient with Microsoft Word and Excel (advanced skills preferred)
- Must possess exceptional organizational and time management skills with ability to work on specified projects to tight timelines
- Work well on a virtual team and with capability to work independently where needed
- Demonstrated ability and willingness to conduct routine work, such as data entry to a high standard of accuracy, while displaying flexibility and independence in spotting or anticipating/resolving problems
- Excellent computer skills in standard office programs and must be able to learn new computer systems quickly.
Offering: 12 Month Contract working in Cambridge
If this role sounds interesting, please get in touch via email or phone. Send your CV to Leanne@xplorepharma.com
This role is urgent, and with the high volume of applicants we may not be able to get in touch with everyone. Interviews will happen as and when a great candidate gets in touch.
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