QA Analyst Level II (Pune or Bengaluru, INDIA)
Anju Software, Inc. specializes in delivering advanced solutions specifically designed for healthcare. Anju provides a comprehensive suite of clinical trial capabilities that can be mixed and matched to build a solid foundation for each trial environment.
The Quality Assurance Analyst II (“QA II”) is responsible for implementing Quality Assurance Software Change Control policies and programs. The QA Analyst will execute the quality assurance and software change disciplines as directed by the Director Quality Assurance. The QA Analyst II will work as a member of a cross functional team including clinical staff, product analysts, software engineers, and QA analysts, so effective communication, collaboration, and team work is essential for success.
Professional; adaptability; possess strong teamwork building capabilities; excellent time management skills; strong communication skills to articulate complex technical issues; self-starter with ability to work within a large team environment.
- Responsible for providing leadership in all activities related to the quality and releasing of software testing.
- Manage several QA testing and assurance plans on multiple projects.
- Develop program test plans for developed systems and subsystems.
- Perform testing of developed and co-developed systems and subsystems.
- Ensure that full project tests are conducted at regular intervals throughout a project.
- Ensure that related test plans are run for all changes made to the system.
- Responsible for ensuring the software complies with the requirements set forth in the FDA guideline 21 CFR Part 11.
- Assist in the identification and resolution of program, system and subsystem deficiencies.
- Enter into, maintain and close software related issues in the Issue Tracking database.
- Ability to identify process improvements.
- Assist with software releases, technical specifications and other engineering tasks as needed.
- Assemble client specific software validation packages.
- Bachelor’s degree in related field of study.
- 2+ years of work experience in the software quality assurance field.
- Must be knowledgeable of software quality assurance and change control concepts, practices and procedures and have extensive experience and judgment in planning, implementing and accomplishing related goals.
- Have technical experience to include but not limited to .NET framework, Microsoft SQL Server Database, Quality Center, Test Director, and QTP.
- Familiar with Quality Assurance in FDA regulated industry.
- Experience working within a Software Development Lice Cycle ("SDLC") process.
- Clinical software experience strongly preferred.
- One or more certifications strongly desired: Six Sigma, Belt Certified, SQA, SCE, CQE, Certified Clinical Data Manager, Certified Clinical Project Manager, Certified Quality Assurance Specialist.
- Familiarity with Bio Pharmaceutical experience preferred.
Job Type: Full-time
Location: Pune or Bengaluru, INDIA
Salary: Based on experience