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Job Descrption

The Quality Assurance Specialist will ensure the effective administration, monitoring, and completion of the Pharmaceutical Quality System, including review and approval of Site Policies, SOPs, Work Instructions, logs, and forms, ensuring compliance with those procedures.
Provide Technical Quality support to the Analytical Services for new and ongoing projects, including review and approval of:

Test Data, Calculations, results, and Certificate of Analysis
Temperature Data
Support investigations, review and approve Deviations, Out of Specifications results, and Requests for Change, considering GMP conformance and compliance with Regulatory guidelines.
Conduct self-inspection audits and maintain site metrics to present a Quality Management Review.
Assist in external inspections, supporting the QA Director.
Review non-compliance identified by audit, deviations, and complaints, using technical/professional judgment to make appropriate quality decisions and initiate quality improvements... to prevent recurrence.
Team player, able to manage different stakeholders and policy processes.
Flexible, able to juggle demands and manage competing priorities.
Self-motivated, required to work on their own initiative and largely independently on key responsibilities under the supervision of the Quality Director.
Consistency of attitude and behavior towards all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organization.
will also be required to train other personnel in quality system procedures and approaches.
Responsible for adhering to CatSci Ltd SOPs, Health & Safety, GMP, and other regulatory guidelines; Educated to degree level (or relevant industry experience in Pharmaceutical Science).
Experience in regulatory audits.
Experience in working in a regulated environment and managing projects.
Evidence of continued professional development.

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