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Permanent

Regulatory and Quality Assistant

Bolton
money-bag 35000.00-35000.00 Annual
Posted 2 days ago

Job Title: Regulatory and Quality Assistant Employment: Full-time, On-site Hours: 40 hours per week Salary: 35,000 per annum Reporting to: Responsible Person (RP) Location: Bolton The Regulatory and Quality Assistant supports the effective operation of the Quality Management System (QMS) and ensures compliance with Good Distribution Practice (GDP) and wider GxP requirements. Working closely with the Responsible Person (RP) and Quality team, this role helps maintain high standards of product quality, safety, and regulatory compliance across all pharmaceutical distribution activities. The position also includes general administrative duties and basic accounts support, with full training provided. Key Responsibilities: Assist in the day-to-day maintenance and continual improvement of the QMS in line with GDP and GxP requirements. Support the creation, review, and updating of Standard Operating Procedures (SOPs) and controlled documents. Maintain accurate and organised quality documentation to ensure audit readiness. Assist in ensuring operational compliance with MHRA guidelines, GDP, and relevant regulatory requirements. Support preparations for internal audits and external inspections such as MHRA. Assist in the follow-up and closure of audit findings, including CAPAs (Corrective and Preventive Actions). Support the management of deviations, change controls, and non-conformances, ensuring timely and accurate documentation. Assist with customer complaints, product returns, ..... full job details .....

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