Roles & Responsibilities :
- Develop comprehensive test plans and strategies based on project specifications and requirements.
- Perform manual and automated testing of software applications, including functional, regression, and performance testing.
- Document and report defects identified during testing and collaborate with development teams for resolution.
- Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance.
- Validate test scenarios against feature acceptance criteria and customer expectations.
- Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
- Identify opportunities to enhance testing efficiency and minimize manual efforts.
- Evaluate and adopt tools and technologies to improve automation capabilities.
- Keep validation documentation updated and aligned with GxP standards.
- Ensure strict adherence to change management processes for validated systems.
- Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP.
- Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms.
Basic Qualifications and Experience :
Master's degree and 1 to 3 years of Life Science / Biotechnology / Pharmacology / Information Systems experience ORBachelor's degree and 3 to 5 years of Life Science / Biotechnology / Pharmacology / Information Systems experience ORDiploma and 7 to 9 years of Life Science / Biotechnology / Pharmacology / Information Systems experienceFunctional Skills : Must-Have Skills :
Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technologyExperience with Agile software development methodologies (Scrum)Excellent communication skills and the ability to interface with senior leadership with confidence and clarityExperience in writing requirements for development of modern web applicationStrong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11.Proficiency in automation tools, data systems, and validation software.Good-to-Have Skills :
Demonstrated expertise in a scientific domain area and related technology needsUnderstanding of scientific software systems strategy, governance, and infrastructureFamiliarity with low-code, no-code test automation softwareTechnical thought leadershipAble to communicate technical or complex subject matters in business termsKnowledge of DevOps, Continuous Integration, and Continuous Delivery methodologySkills Required
Problem Solving, Gxp, Sql