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Role at a glance
You will
Developing and executing validation plans, protocols, and reports for software, systems, and processes to ensure compliance with regulatory…
Conducting risk assessments and impact analyses to identify potential issues and recommend appropriate validation strategies.
Must-have skills
Clinical Research
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Job description
Location: Chennai Department: Operations
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.
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.
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%).
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
