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Clinical QA Specialist

Responsibilities:

  • Plan and support internal/external audits of clinical sites, vendors, and trial processes.
  • Ensure compliance with ICH-GCP, regulatory standards, and company SOPs.
  • Review and approve clinical trial documents (protocols, informed consent forms, study reports).
  • Oversee clinical documentation in the company’s control system.
  • Provide GCP training and develop compliance programs.
  • Identify risks, conduct root cause analyses, and implement CAPAs.
  • Collaborate with clinical, regulatory, and QA teams to align on quality standards.
  • Lead quality improvement initiatives and stay updated on industry trends.

 

Requirements:

  • Education: Bachelor’s degree in life sciences, pharmacy, or related field.
  • Experience: Minimum 2–3 years in clinical QA or related roles.
  • Strong knowledge of GCP, regulatory compliance, and quality management systems.
  • Proficiency in written and spoken English, with excellent technical writing skills.
  • Strong attention to detail and organizational skills.
  • Effective communication and collaboration abilities.
  • Problem-solving skills, including root cause analysis and risk management.
  • Ability to manage multiple tasks and prioritize in a fast-paced environment.

Come work with us

Clinical QA Specialist

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