Quality Assurance Specialist at MSD | London, United Kingdom | Rezi

Quality Assurance Specialist at MSD

Quality Assurance Specialist

MSD · London, United Kingdom

6 days ago

Quality Assurance Specialist

MSD · London, United Kingdom

6 days ago
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About the Role

Play a key role in GMP Quality Assurance activities supporting our GDQ IMP Licence, partnering across functions to shape quality standards and ensure products meet the highest regulatory and ethical benchmarks.

Responsibilities

  • 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.

Requirements

  • 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 prioritizing 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.

Skills

  • Auditing
  • Complaints Investigation
  • Compliance Reporting
  • Data Analysis
  • GMP Compliance
  • Good Manufacturing Practices (GMP)
  • Investigation Management
  • Process Improvements
  • Quality Assurance (QA)
  • Quality Control Management
  • Quality Management
  • Regulatory Compliance
  • Regulatory Requirements

Location

  • London

Work Type

  • Hybrid
  • Regular

Education Level

  • Bachelor’s degree in a life science or related discipline

About the Company

  • 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 place, introductions are position specific. Please, no phone calls or emails.