Quality Operations Specialist

• Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents.
• Administrate documents on the document management system acting as the primary document coordinator.
• Provide support to users of the document management system.
• Act as the primary point of contact for the storage of Quality Documents within the ExM Document Archive and offsite storage.
• Maintain the Learning Management System (LMS) as required including management of items, objects, tasks and authorised instructors.
• Create and or update online assessment on the LMS
• Assist EHS and Quality departments in tracking compliance-based training completion for the site, through the provision of metrics or LMS reports as necessary
• Maintenance of all curricula on the system including annual curricula review
• Scheduling training – both internal and external
• Ensuring all training or documentation records are processed in a timely manner with the utmost attention to detail and meet Good Documentation Practices (GDP) requirements
• Author and review quality systems related procedures as required.
• Support the management of quality documents and records
• Support the on boarding of new personnel.
• Provide regular communications on the document management system or Training system.
• Collate metrics on a monthly basis.
• Deliver training to all relevant site personnel
• Prepare trend and status reports as required.
• Prepare and update training documents, courses and assessments.
• Communicates document issues or training issue and escalates as appropriate.
• Liaise with personnel for efficient review and approval of documents on DCA.
• Support Audits or inspections as required

• A minimum of 6 months experience in a pharmaceutical environment or other regulated industry.
• Preferably a working knowledge of Document Management Systems or Training administration.

PE Global