Quality Assurance Specialist

Merck Gruppe - MSD Sharp & Dohme; City Of London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in London seeks a QA Specialist to lead GMP quality assurance activities. The candidate will perform audits, review documentation, and support compliance initiatives. A Bachelor's degree in life science and applied experience in Quality roles are required. This position offers the opportunity to impact patient safety and regulatory compliance.

Benefits

Collaborative environment

Opportunities for professional growth

Qualifications

• Applied professional experience in pharmaceutical Quality roles.
• Proven ability to lead and contribute as a team player.
• Demonstrated understanding of GMP and solid technical knowledge.

Responsibilities

• Lead and perform GMP audits to ensure compliance.
• Review and approve production and analytical documentation.
• Support product recalls and stock recoveries.

Skills

Accountability

Data Analysis

Documentation Review

GMP Compliance

Good Manufacturing Practices (GMP)

Manufacturing Compliance

Process Improvements

Product Recalls

Quality Assurance (QA)

Quality Assurance Systems

Regulatory Compliance

Regulatory Requirements

Teamwork

Training and Development

Education

Bachelor’s degree in a life science or related discipline

Tools

Microsoft applications

GMP-related software

Job description

Job Description

Make a real impact on patient safety and product quality. Join our Global Development Quality (GDQ) team in London as a QA Specialist, where you’ll play a key role in GMP Quality Assurance activities supporting our GDQ IMP Licence. You’ll partner across functions, shape quality standards, and help ensure our products meet the highest regulatory and ethical benchmarks.

What you’ll do

• Lead and perform GMP audits to ensure compliance with SOPs, GMPs, and applicable regulations
• Review and approve production and analytical documentation for drug substance, drug product, and packaged finished goods, supporting QP certification
• Collaborate across functional teams to resolve comments and issues identified during audits and reviews
• Support product recalls and stock recoveries when required
• Identify compliance gaps and drive continuous improvement initiatives
• Create, update, and maintain assigned SOPs
• Perform and review complaints, deviation investigations, change controls, and CAPAs
• Contribute to onboarding and training of new starters and colleagues
• Follow standard procedures and consult with your manager to resolve exceptions
• Compile data for reports and presentations, interpret findings, and draw actionable conclusions
• Deliver work to high standards of compliance, efficiency, innovation, accuracy, and safety
• Stay current with cGMP requirements and evolving global regulations
• Represent GDQ on cross-functional teams and support additional activities as assigned

What you’ll bring

• Bachelor’s degree in a life science or related discipline
• Applied professional experience in pharmaceutical Quality roles
• Strong, collaborative communication skills and a self‑motivated mindset
• Demonstrated understanding of GMP and solid technical knowledge
• Proven ability to lead and contribute as a team player; capable of prioritising and delivering across multiple projects and tasks
• Advanced problem‑solving and sound decision‑making skills
• Proficiency with Microsoft applications and readiness to learn and use GMP‑related software

Why join us

• Be part of a mission‑driven team ensuring products are safe, effective, and compliant
• Work in a collaborative environment with clear impact on regulatory success and patient outcomes
• Opportunities to grow your expertise across audits, quality systems, and cross‑functional projects

Ready to elevate quality with us? If this sounds like your next step, we’d love to hear from you.

Closing date for applications: 23/11/2025

Required Skills

Accountability, Data Analysis, Documentation Review, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Compliance, Process Improvements, Product Recalls, Quality Assurance (QA), Quality Assurance Systems, Regulatory Compliance, Regulatory Requirements, Teamwork, Training and Development