Quality Systems Associate

4 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Responsibilities


• 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.

Training Administration


• 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

General


• 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

Designee Responsibilities

This role can act as designee for other Quality system Associate roles

Contingency Support Quality System Senior Specialist or Quality System Manager or Quality systems senior manager will provide backup for this role

Competencies Essential


• Good time management and organizational skills


• Ability to multi-task numerous projects


• Ability to work with initiative


• Good interpersonal skills


• Good communication and presentation skills

Desirable


• Confident public speaker


• Flexible and motivated


• Ability to achieve targets and milestones

Qualification(s) and Desired Experience


• 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

Responsibilities


• 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.

Training Administration


• 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

General


• 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 excalates as appropriate.


• Liaise with personnel for efficient review and approval of documents on DCA.


• Support Audits or inspections as required

Designee Responsibilities This role can act as designee for other Quality system Associate roles

Contingency Support Quality System Senior Specialist or Quality System Manager or Quality systems senior manager will provide backup for this role

Competencies Essential


• Good time management and organizational skills


• Ability to multi-task numerous projects


• Ability to work with initiative


• Good interpersonal skills


• Good communication and presentation skills

Desirable


• Confident public speaker


• Flexible and motivated


• Ability to achieve targets and milestones

Qualification(s) and Desired Experience


• 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

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