Quality Systems Specialist - Initially a 12 month contract 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: QMS Biotech
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