Quality Assurance Specialist - Pharmaceutical, GDP

Quality Assurance Specialist | Pharmaceutical | GDP

📍 Location: Borehamwood, Hertfordshire

🏢 Working Pattern: 5 days per week on site

We are working with an ambitious, fast-growing and multi-faceted pharmaceutical business operating across both UK and international markets, who are looking to appoint an experienced Quality Assurance Specialist to join their expanding Quality function.

This is an exciting opportunity for an established QA professional looking to take on a senior-level position, with real responsibility for regulatory compliance, quality oversight and continuous improvement.

The business operates in a fast-paced, commercially driven and entrepreneurial environment. Having invested significantly in its people, systems and infrastructure, it is continuing to develop and strengthen its Quality function.

The Opportunity

This is a senior position with a particular emphasis on Good Distribution Practice (GDP), providing quality and regulatory oversight across the business’s operational activities.

Working closely with the Head of Quality, Lead Quality Assurance Specialist and Responsible Person (RP), you’ll play an important role in maintaining and developing the Quality Management System, ensuring regulatory compliance and supporting the continued growth of the business.

You’ll also act as a senior QA point of reference, providing technical guidance, supporting junior colleagues and helping drive improvements across the wider organisation.

Key Responsibilities:

• Maintain and continuously improve the Quality Management System (QMS) in line with GDP, GMP and MHRA requirements.
• Provide regulatory oversight across operational, warehouse, import/export and distribution activities.
• Support Responsible Person (RP) and Responsible Person for Import (RPi) delegated duties, as appropriate.
• Review, investigate and approve deviations, CAPAs, change controls, complaints, SOPs and risk assessments.
• Support MHRA regulatory inspections, customer and supplier audits, internal audits and self-inspections.
• Assist with licence variations, major change controls and ongoing compliance with relevant regulatory licences.
• Coordinate product recalls in partnership with the Responsible Person.
• Support supplier, customer and third-party qualification and quality agreements.
• Provide technical guidance, training and mentoring to colleagues across the business.
• Identify opportunities to improve processes, strengthen compliance and develop a positive quality culture.

What We’re Looking For:

• Strong experience within a pharmaceutical Quality Assurance environment.
• A solid understanding of GDP and MHRA regulatory expectations.
• Good working knowledge of WDA(H) licence requirements.
• Experience maintaining and improving Quality Management Systems.
• Exposure to deviations, CAPAs, change controls, complaints, audits and regulatory inspections.
• Understanding of GMP would also be beneficial.
• Excellent communication, organisational and problem-solving skills.
• Someone proactive, commercially aware and comfortable taking ownership.

The Person:

This is an important appointment, and personality and approach will be just as important as technical experience.

We’re looking for someone who is:

• Hardworking, committed and genuinely passionate about Quality.
• Comfortable operating in a fast-paced, entrepreneurial environment.
• Able to manage multiple priorities, work with urgency and adapt quickly.
• Confident enough to challenge processes and bring forward ideas.
• A collaborative team player who is happy to roll up their sleeves and support colleagues.
• Someone who takes accountability, shows initiative and understands the importance of going above and beyond.

What’s on Offer?

• A senior-level position within an ambitious and growing pharmaceutical business.
• The opportunity to influence and improve quality processes.
• Exposure to a broad range of GDP and regulatory responsibilities.
• A collaborative environment where ideas and initiative are encouraged.
• Opportunities for professional development and progression.
• Competitive salary and benefits package, including bonus.

If you’re an experienced pharmaceutical QA professional with strong GDP knowledge and are looking for a position where you can genuinely make an impact, we'd be very interested in speaking with you.

Keywords: Quality Assurance Specialist, Senior QA Specialist, QA Specialist, Pharmaceutical, Pharmaceuticals, GDP, Good Distribution Practice