Senior Validation Analyst

Job Description:

Responsibilities

• 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.

Qualification & 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.