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Job Description
Requirement:
- Bachelor's degree in Engineering, Computer Science, or a related field.
- 5+ years of experience in software validation or a related field.
- Strong knowledge of validation principles, methodologies, and regulations (GAMP, FDA, etc.).
- Experience in performing risk assessments and generating risk-based validation strategies.
- Experience in generating validation documentation, such as validation plans, protocols, and reports.
- Knowledge of software development life cycle (SDLC) and software testing concepts.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Attention to detail and a commitment to delivering high-quality work.
- Ability to mentor and lead small projects
Responsibilities:
- Hands-on work in an individual capacity leading to deliverables
- Diligently work with Product, Engineering, and Testing teams to gain an understanding of Product functions.
- Review Product Requirements including Epics, User stories, User Requirements, Software Requirements, etc.
- Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines
- Create realistic test cases and test data based on customer usage scenarios.
- Execute test cases, create defects, create deviations, and report test results.
- Peer review Test cases, test data, and Test designs
- Work in a highly collaborative team environment, with communication across many team members.
- Good understanding of the company QMS standards
- Author documents in accordance with the QMS guidelines
- Ability to manage a team - Allocate work, review work and guide
- Manage complete validation of products
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.