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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.