Clinical QA Specialist - 209

We are seeking an experienced Clinical QA Specialist to Join Our Team!

Are you passionate about ensuring high-quality standards in clinical trials and making a meaningful impact on healthcare innovation? As our Clinical QA Specialist, you will play a vital role in upholding compliance with regulatory requirements, GCP guidelines, and company policies. Join us in maintaining excellence and integrity in our clinical programs!

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.