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QA Specialist

JR United Kingdom

England

On-site

GBP 40,000 - 70,000

Full time

Yesterday
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Job summary

Join a global pharmaceutical organization as a Quality Assurance Specialist, where you will play a crucial role in ensuring compliance with Good Manufacturing and Distribution Practices. This position offers the opportunity to oversee quality activities, manage product releases, and engage in continuous improvement initiatives. You will work closely with health authorities and internal stakeholders to uphold the highest standards of quality and regulatory compliance. If you are passionate about driving operational excellence in the pharmaceutical industry, this role is perfect for you.

Qualifications

  • 5+ years of experience in Quality Assurance or related roles.
  • Strong understanding of GMP, GDP, and regulatory guidelines.

Responsibilities

  • Oversee product release and compliance processes.
  • Manage and enhance Quality Systems and CAPAs.

Skills

Quality Assurance
Good Manufacturing Practices (GMP)
Good Distribution Practices (GDP)
Regulatory Affairs
Risk Assessment
Continuous Improvement

Education

Bachelor's degree in Pharmacy or related field

Tools

Quality Management Systems

Job description

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Your new company
A global pharmaceutical organisation committed to ensuring the highest standards of quality and compliance in the commercialisation of medicinal products. This company is dedicated to continuous improvement and regulatory excellence, working closely with health authorities, contract manufacturers, and internal stakeholders to uphold strict industry standards.
Your new role
As a Quality Assurance Specialist, you will be responsible for managing quality activities to ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for medicinal products. Your key duties will include:

  • Overseeing the product release and compliance process, verifying documentation completeness, and ensuring adherence to quality standards.
  • Maintaining and enhancing Quality Systems, including Change Control, Deviations, Complaints, Product Quality Reviews (PQRs), Recalls, and Returns.
  • Acting as a liaison with Health Authorities, ensuring timely reporting of quality incidents and overseeing compliance with company policies.
  • Managing risk assessment and documentation, supporting technical knowledge-sharing within the organisation
  • Implementing and monitoring Corrective and Preventative Actions (CAPAs), tracking effectiveness, and preparing reports for senior leadership.
  • Engaging in continuous improvement initiatives to drive operational excellence.


What you'll need to succeed

  • Bachelor's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Biochemistry, or a related field.
  • Minimum of 5 years of experience in Quality Assurance, Quality Control, or a related function within the pharmaceutical or healthcare industry.
  • Certifications in GMP and GDP
  • Strong understanding of regulatory affairs, quality assurance, and pharmaceutical guidelines.
  • Proven experience managing quality systems, pharmaceutical product releases, and compliance-related activities such as Change Control, CAPAs, and Deviations.
  • Demonstrated ability to lead or participate in quality improvement projects.
  • Previous exposure to regulatory audits and interactions with Health Authorities is highly desirable.


What you need to do now
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