Katalyst Healthcares and Life Sciences
Responsibilities:
- Develop and implement CSV workflows, analyse system solutions and support validation protocols, reports and other applicable documentation.
- ssure validation activities are conducted in a compliant and timely manner.
- Evaluate and audit software documentation and processes.
- Provide guidance and recommendations to software users on qualification/validation requirements.
- Collaborate with stakeholders to validate system solutions.
- Develop and manage validation documentation and databases.
- Lead risk assessments and analyse validation test data.
- Identify and mitigate software validation gaps.
- Remains current on new and emerging best practices for software validation.
- 7+ years of CSV experience with at least 5 years' experience in a regulated industry (medical device, auto, aerospace manufacturing QMS environment).
- Bachelor's degree in software engineering, computer science, IT, or data science.
- Experience in validation activities in medical device industry, specifically meeting FDA 21 CFR Part 11 compliance.
- Excellent technical skills and project management abilities.
- ssociate's degree in applied science (or relevant certificates with proven experience).
- Proficiency in regulatory and quality regulations (ISO 13485:2016, FDA 21 CFR 820, FDA 21 CFR Part 11).
- Subject matter expert of software validation industry standards and current regulatory environment to provide technical guidance and expertise related to regulatory compliance.
- Experience in managing validation projects.
- ble to prepare written reports and give presentations to all levels of the organization.
- Strong technical writing and computer skills.
- Excellent communication, leadership, and problem-solving abilities.
- bility to travel up to 10%.