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Job Title: Regulatory & 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 & 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, and product recall processes.
Support supplier and customer qualification activities, ensuring records remain current and compliant.
Monitor and document temperature-controlled storage and transportation activities.
Assist in maintaining pest control documentation and ensuring compliance with site standards.
Support Computer System Validation (CSV) activities and maintain validated systems used across operations.
Use strong andheavyIT literacy to understand how systems function, troubleshoot issues, and support digital process improvements.
Work confidently with or be prepared to learn SQL databases, Power Query, and Power BI to support data extraction, reporting, and quality metrics.
Contribute to data integrity, system documentation, and continuous digital optimisation projects.
Maintain training records, ensuring staff GDP/GxP training is up to date.
Support coordination and delivery of internal quality and compliance training sessions.
Provide administrative support to the Responsible Person and Quality/Regulatory team.
Support basic accounts tasks such as document processing, filing, budget tracking, and data entry (full training provided). Participate in quality meetings, preparing minutes and action logs.
Essential Skills & Qualifications:
A-Levels or equivalent; a science-related degree is advantageous but not essential with relevant experience.
Experience in a quality assurance or administrative role within a regulated environment such as pharmaceutical or healthcare.
Good understanding of GDP and general GxP principles.
Ability to manage day-to-day QA tasks with limited oversight.
Heavy IT literacy, able to understand not only how to use systems but how they work behind the scenes, including data structures and system logic.
Experience with SQL, Power Query, or Power BI is highly advantageous.
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
Excellent attention to detail and documentation accuracy.
Strong organisational and time-management abilities.
Clear written and verbal communication skills.
Proactive, analytical, and methodical approach to problem-solving.
Able to work independently and collaboratively within a small team.
Discreet and reliable when handling confidential information.
Commitment to learning, development, and maintaining high-quality standards.
