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Quality Assurance Specialist

3 months ago

Hoddesdon, Hertfordshire, United Kingdom Pharmaron Full time

Quality Assurance Specialist

Pharmaron is on the lookout for a Quality Assurance Specialist to establish and uphold an electronic Quality Management System (eQMS) tailored for API and IMP Drug Product Manufacturing.

Key Responsibilities:

  • Develop and assess Standard Operating Procedures (SOPs) and other regulated documents
  • Oversee the distribution of SOPs and related documentation
  • Execute internal audits to ensure compliance
  • Review Quality Systems for effectiveness
  • Facilitate the Vendor Management process
  • Aid in audits conducted by clients and regulatory bodies
  • Monitor Deviations and Change Controls
  • Investigate quality-related issues and trends
  • Manage the Training System
  • Supervise the archiving of GMP documentation
  • Foster a culture of excellence in Quality
  • Ensure adherence to GMP standards

Qualifications:

  • Bachelor’s degree in chemistry or a related scientific discipline
  • Minimum of 2 years’ experience in Quality Assurance
  • Familiarity with eQMS and GMP regulations
  • Strong organizational and leadership capabilities
  • Proficient communication skills within the organization
  • Experience with MS Project and Office Suite

About Pharmaron:

Pharmaron stands as a premier contract research organization within the pharmaceutical sector, committed to scientific excellence and ethical standards. We offer research services to leading pharmaceutical firms, addressing intricate scientific challenges.

Join our team and engage with advanced facilities for API development and formulation. We provide a competitive salary, extensive benefits, and a collaborative work environment.

  • Opportunities for professional growth and development
  • Engage in challenging technical projects
  • Commitment to excellence at the heart of our operations