Regulatory and Quality Assistant

SKC Recruitment; Bolton; On-site; GBP 35,000; Full time

Job summary

A recruitment agency is seeking a Regulatory & Quality Assistant in Bolton for full-time employment. The role involves supporting the Quality Management System, maintaining compliance with Good Distribution Practice, and assisting with documentation and audits. Essential skills include strong IT literacy, experience in quality assurance, and proficiency in tools like SQL and Power BI. Join a dynamic team ensuring high standards in pharmaceutical distribution.

Qualifications

• Experience in quality assurance or administrative role in a regulated environment.
• Good understanding of GDP and GxP principles.
• Ability to manage QA tasks with limited oversight.

Responsibilities

• Assist in daily maintenance of the Quality Management System.
• Support the creation and updating of Standard Operating Procedures.
• Prepare for internal audits and manage audit findings.

Skills

Attention to detail

Organisational skills

Proficiency in MS Office

IT literacy

SQL knowledge

Communication skills

Education

A-Levels or equivalent

Science-related degree (advantageous)

Tools

Power BI

Power Query

SQL databases

Job description

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.