Quality Compliance Auditor

Location: Craigavon / Derry-Londonderry / Dundalk

Hours: 37.5 Hours per week

Salary: Competitive

Business Unit: Clinical Services

Open To: Internal and External Applicants

Ref No.: HRJOB10990

The Role

The Quality Compliance Auditor has a critical role in ensuring Drug Substance and Drug Product manufacture is performed in accordance with GMP and regulatory submissions. The main objective of this position is to maintain compliance with Product Specification File, IMPD, and CTA requirements in line with internal timelines and customer/regulatory expectations.

The Quality Compliance Auditor will proactively liaise with customers, QP Services personnel, project contacts, and stakeholders to gather the necessary batch documentation. They will monitor and resolve any issues efficiently through teleconferences and close collaboration with relevant internal and external stakeholders while maintaining a high level of customer service. In addition, the Quality Compliance team must review deviations, change controls, and annotations, and scrutinize Certificates of Analysis to ensure compliance with regulatory requirements. They must also highlight areas of concern and provide clear and concise queries and their subsequent responses to clients.

The Quality Compliance Auditor will be an expert in IMPs, country-specific requirements, and clinical trial legislation relating to Clinical Services business. They will work closely with their assigned customers, develop relationships, and host product specific calls prior to reviewing new product documentation. It is critical for this role to maintain excellent oversight of workload to ensure all activities are completed within the customer’s expectations and department KPIs while prioritizing daily activities independently.

They must be familiar with GMP principles and internal SOPs and maximize efficiency through successful time management. Additionally, they are expected to proactively escalate issues to the Quality Compliance Team Leader and the Quality Compliance Group Manager while fostering a positive working environment within the team of Quality Compliance Auditors.

Key Requirements

• Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time, permanent employment in the UK
• Bachelor’s Degree in Biology, Pharmacy, Chemistry or related subject (or equivalent)
• Experience in a manufacturing environment

Desirable Requirements

• Experience in the generation or review of manufacturing batch records, change controls and or deviations
• Experience in a customer facing role

Further Information

This role is based on a full flex working pattern of 06:00 – 19:00 with a minimum 5 hours per day. This role will also be eligible for hybrid working following the successful completion of probation.

Apply Now

Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

Closing Date

We will no longer be accepting applications after 5pm on 05 October 2025

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.