Quality Assurance Specialist

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

Preferred Skills
Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid

Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
11/24/2025

• A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R372875