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.