Quality Systems Specialist Limerick

IrishJobs

Limerick, Wexford, Ireland

Limerick, Wexford, Ireland

À propos

Kenny-Whelan(a specialist division of the CPL group) are hiring a Quality Systems Specialist supporting our US Biopharma client in Raheen Limerick ContactElaine Cahill on or email Quality System Specialist Limerick *Ensure that the QMS is managed, developed and implemented appropriate to the activities of the company and all relevant requirements. *Liaise with all departments to ensure documentation in use complies with customer requirements, regulatory, and external quality standards and is 'audit ready' at all times. *Liaise with external auditors to schedule audits and monitor the completion of corrective actions in a timely manner to ensure certification is maintained. *Develop, implement and update QMS policies, procedures and templates and circulate as required. Maintain document control on all documentation. *Ensure the latest versions of documents are available where needed and that users have the correct access. *Ensure previous versions of the QMS and external standards are saved correctly and retrievable if required. *Monitor and maintain the retention times for document storage to ensure that the documentation is retained in a suitable manner to allow retrieval if required. *Ensure that any changes to system requirements are implemented competently, in a timely manner and that all affected parties are made aware of any changes. *Provide training and support to employees on document management procedures and QMS requirements. *Serve as a resource for internal stakeholders seeking guidance on document-related matters. *Review documents completed by other departments and update /correct where necessary. *Actively participate in and implement continuous improvement projects related to the QMS. *Support the Internal Audit system and the retrieval of documentation as required. Requirements: *Bachelors degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences or a related Life Sciences field *5+ years of experience in quality systems within a regulated industry. *Hands-on experience administering or supporting eQMS modules (Document Control, Training, Change Control, CAPA, Audits, Risk Management). *Experience leading cross-functional investigations, risk assessments, and continuous improvement projects. Skills: q

TLNT1_IJ

Limerick, Wexford, Ireland

Compétences linguistiques

English

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