Test Lead Engineer - Automation Testing (10-15 yrs)

Key Responsibilities :

- Develop and implement the test automation strategy, ensuring alignment with overall project goals and timelines.

- Design, develop, and maintain automated test scripts using industry-standard tools and frameworks.

- Ensure comprehensive test coverage by identifying and automating test cases for functional, regression, performance, and load testing.

- Continuously improve and optimize the test automation framework and processes.

- Conduct code reviews and provide feedback to ensure the quality and maintainability of automated test scripts.

- Monitor and analyse test results, identifying and reporting defects, and working with development teams to resolve issues.

- Ensure that automated tests are integrated into the continuous integration/continuous deployment (CI/CD) pipeline.

- Collaborate with cross-functional teams, including developers, product managers, and QA engineers, to define and prioritize automation testing requirements.

- Create and maintain detailed documentation for test automation processes, frameworks, and scripts.

Generate and present test reports, metrics, and dashboards to stakeholders, providing insights into the quality and stability of the software.

- Stay up-to-date with the latest trends and best practices in test automation and quality assurance.

- Identify opportunities for process improvements and implement changes to enhance the efficiency and effectiveness of the testing process.

- Provide training and support to team members and other stakeholders on test automation tools and practices.

- Develop and review of Computer System Validation Artifacts including Validation Master plans, Requirements Specification, Design Specifications, Test Plans (System Test, User Acceptance Test, Installation Qualification), Test Summary Reports (System Test, User Acceptance Test, Installation Qualification), Traceability Matrix, Validation Summary Report, Release for Use Memo, SOP's, Work Instructions.

- Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation.

- Ensure that the validation artifacts meet the quality requirements and applicable regulations FDA, EU, Corporate & International Standards.

- Collaborate with Validation Cross Functional Teams at corporate and related to management, peers and junior professionals.

- Lead the team in preparation for regulatory, internal, and corporate audits and inspections.

Qualifications & Experience :

- The Test Lead should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline along with 10+ years' of experience in software testing and test automation, with at least 2 years in a leadership or senior role.

- Good technical understanding of IT Infrastructure, manufacturing execution systems and its integration with process automation systems (DeltaV), LIMS (Labware), SAP/Oracle is desirable.

- Knowledge of Automation testing tools (e.g, Selenium, QTP, Appium).

- Strong understanding of test automation frameworks (e.g, TestNG, JUnit).

- Strong Knowledge of programming languages (e.g Java, Python, C#) .

- Experience with CI/CD tools (e.g, Jenkins, Bamboo).

- Understanding of the integration of testing processes within CI/CD pipelines.

- Knowledge of FDA regulatory validation requirements including FDA (21CFR, part 11), EMA (Annex 11), GAMP and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9).

- Relevant experience with data integrity requirements and implementation in a GMP environment.

- Knowledge of Quality principles, computer system development lifecycles, QA methodologies, S88 batch control standards and the and ISA-95 manufacturing plant levels.

- Problem solving ability, Critical thinking, and ability to effectively communicate with technical and non-technical stakeholders.

- Strong service delivery, time, project, and priority management skills.

- Experience dealing with regulatory agencies and global audit teams is desirable.