Clinical QA

Responsible for ensuring compliance with regulatory requirements, GCP guidelines, and company policies. Manages clinical quality systems, conducts audits, and supports clinical teams to uphold high-quality standards in clinical trials.

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.