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Title
Text copied to clipboard!Validation Analyst
Description
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We are looking for a highly detail-oriented Validation Analyst to join our team. The Validation Analyst plays a critical role in ensuring that systems, processes, and data meet regulatory and quality standards. This position is essential in industries such as pharmaceuticals, biotechnology, finance, and information technology, where compliance and accuracy are paramount.
As a Validation Analyst, you will be responsible for developing and executing validation protocols, analyzing data, and preparing documentation to support validation activities. You will work closely with cross-functional teams including Quality Assurance, Regulatory Affairs, IT, and Engineering to ensure that all systems and processes are validated according to internal policies and external regulations.
The ideal candidate will have a strong background in data analysis, quality assurance, and regulatory compliance. You should be comfortable working in a fast-paced environment and possess excellent organizational and communication skills. Familiarity with industry standards such as GxP, FDA 21 CFR Part 11, and ISO guidelines is highly desirable.
Key responsibilities include creating validation plans, test scripts, and reports; performing risk assessments; and ensuring traceability of requirements throughout the validation lifecycle. You will also be expected to stay current with industry trends and regulatory changes to ensure ongoing compliance.
This role offers an exciting opportunity to contribute to the integrity and reliability of critical systems and processes. If you are passionate about quality and compliance and enjoy working with data and documentation, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Develop and execute validation protocols and test scripts
- Perform risk assessments and impact analyses
- Ensure compliance with regulatory standards and internal policies
- Collaborate with cross-functional teams to gather validation requirements
- Document validation activities and maintain traceability matrices
- Analyze validation data and prepare summary reports
- Support audits and inspections by providing validation documentation
- Maintain up-to-date knowledge of industry regulations and best practices
- Participate in continuous improvement initiatives
- Ensure timely completion of validation deliverables
Requirements
Text copied to clipboard!- Bachelor’s degree in a relevant field such as Computer Science, Engineering, or Life Sciences
- 2+ years of experience in validation or quality assurance
- Knowledge of regulatory standards such as GxP, FDA 21 CFR Part 11, or ISO
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Proficiency in Microsoft Office and validation tools
- Ability to manage multiple projects and meet deadlines
- Attention to detail and strong organizational skills
- Experience with data integrity and documentation practices
- Ability to work independently and in a team environment
Potential interview questions
Text copied to clipboard!- What experience do you have with validation protocols?
- Can you describe a time you ensured compliance with regulatory standards?
- How do you prioritize multiple validation projects?
- What tools or software have you used for validation activities?
- How do you stay updated on industry regulations?
- Describe your experience with risk assessments.
- Have you participated in audits or inspections?
- What is your approach to documentation and traceability?
- How do you handle tight deadlines and competing priorities?
- What industries have you worked in as a Validation Analyst?
