Senior Specialist - Quality Engineering

Job Title: Senior Specialist - Quality Engineering

Location: Bangalore

Experience: 8-12 years

We are seeking a highly experienced Senior Specialist in Quality Engineering with a strong background in Computer System Validation for our Bangalore team. This role is critical for ensuring the quality and compliance of our life sciences applications through robust testing and validation processes.

Job Description

1. Lead and execute Computer System Validation (CSV) activities for life sciences applications, ensuring adherence to regulatory standards.

2. Oversee Quality Assurance Software Testing activities, from planning to execution and reporting.

3. Develop and optimize IT processes to ensure compliance with relevant regulations and industry standards, including GxP and 21 CFR Part 11.

4. Manage the end-to-end validation process, including the creation of Validation Plans, Reports, and Installation Qualification baselines.

5. Collaborate with project and integration management teams to drive quality throughout application development and maintenance projects.

6. Track, review, and approve all quality deliverables, ensuring accuracy and completeness.

7. Support internal and external audit management activities, providing necessary documentation and expertise.

8. Contribute to the setup and maintenance of Quality Management Systems (QMS), including process definition and SOP creation.