Senior Validation Analyst (Veeva EDC)

• Location: India, Chennai
• Senior Validation Analyst (Veeva EDC) - Office or Home based
• At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
• As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
• As a Senior Validation Analyst at ICON, you will be responsible for ensuring that all systems and processes comply with regulatory standards and internal quality requirements.

What You Will Do

You will lead on scientific operations tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include

• Developing and executing validation plans, protocols, and reports for software, systems, and processes to ensure compliance with regulatory requirements.
• Collaborating with IT, QA, and operational teams to assess validation needs and establish best practices in validation methodologies.
• Conducting risk assessments and impact analyses to identify potential issues and recommend appropriate validation strategies.
• Documenting validation activities and maintaining accurate records to support audits and inspections.
• Providing training and guidance to junior analysts, fostering a culture of quality and compliance within the team.

Your Profile

You will have a strong foundation in scientific operations, with the experience to work independently and guide others.

Required qualifications and experience

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field.
• Extensive experience in validation activities within the healthcare, pharmaceutical, or clinical research sectors.
• Strong knowledge of regulatory requirements (e.g., GxP, FDA, EMA) and validation best practices.
• Excellent analytical and problem-solving skills, with a keen attention to detail and accuracy.
• Effective communication skills, with the ability to collaborate with cross-functional teams and convey complex information clearly.
• Willingness to travel as required (approximately 5%)
• Additional Locations: India, Trivandrum, India, Bangalore