Validation (CSA) SME
Validation (CSA) SME
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1 Vacancy
Job Description
- Provide subject matter expertise on validation project risk and complexity.
- Ensure adherence to validation best practices and compliance standards.
- Gather project information and requirements from system stakeholders.
- Collaborate frequently with Business Analysts and cross-functional teams.
- Maintain compliance with Good Documentation Practices (GDP).
- Support authoring and reviewing of validation reports and documentation.
- Collect and integrate feedback from system stakeholders on deliverables.
- Draft and execute GxP Assessments Risk Assessments Validation Plans Test Plans and Validation Summary Reports as needed.
- Review draft and execute additional validation documentation when required.
- Bachelors degree in computer science Information Technology Chemical Engineering Biomedical Engineering or a related field.
- 7 10 years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA).
- Solid knowledge of GAMP 5 and 21 CFR Part 11 standards.
- Prior experience in GxP or life sciences industries required.
- Strong understanding of FDA regulations and compliance requirements.
- Proven experience creating reviewing and resolving CAPAs.
- Ability to work independently while meeting project deadlines.
- Practical knowledge of Data Integrity and ALCOA principles is a plus.
- Technical Competency: Able to translate business requirements into CSV documentation and supporting materials.
- Time Management: Manages strict deadlines and competing priorities effectively.
- Analytical Skills: Applies logical reasoning to identify research and communicate critical information.
- Agility: Adapts to shifting priorities and timelines while maintaining high-quality deliverables.
- Commitment to Quality: Demonstrates strong understanding of CSA prioritizing customer safety data integrity and product quality.
- Extensive experience within medical pharmaceutical or regulatory compliance environments.
- Strong Computer Software Assurance (CSA) expertise; able to serve as the subject matter expert.
- Excellent communication leadership and collaboration skills; positive and approachable demeanours.
- Agile methodology knowledge/experience strongly preferred.
Employment Type
Full-time
