Sumeru Solutions
Location
Mountain View, CA | United States
Job description
Need QA with QMS and life science
Location MTV mountain view
Onsite google position
Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people
manage their health and the way healthcare is delivered. Launched from Google X in 2015, Our
purpose is to bring the promise of precision health to everyone, every day. We are focused on
generating and activating data from a variety of sources, including clinical, social, behavioral and the
real world, to arrive at the best solutions for a person based on a comprehensive view of the
evidence. Our unique expertise and capabilities in technology, data science and healthcare enable
the entire healthcare ecosystem to drive better health outcomes.
Role Description
We are seeking a highly skilled and experienced IT CSV Specialist who will play a crucial role in
planning and executing the validation of computerized systems which support Verily's applications,
medical devices, and quality management system by ensuring compliance with industry regulations
and standards. This individual plays a key role in implementation, maintenance, and retirement of
regulated computerized systems which are considered as non-products.
Role Responsibilities
Work closely with the Quality team to execute software validation, including drafting
deliverables (requirements, test cases, test protocol, test reports, etc.) and executing test
cases.
Work with software vendors and internal cross functional teams to ensure systems are
appropriately validated, implemented, and maintained in accordance with current industry
practices.
Provide CAPA, audit, and overall QMS support in regards to eQMS.
Act as SME for CSV and IT Infrastructure related projects to guide product and IT teams to
ensure that a consistent approach is utilized in the validation and qualification activities.
Qualifications:
Minimum
Associate or Bachelor's degree in related technical field or equivalent practical experience
(3+ years working experience with Associates, 1+ year with Bachelor's)
4+ years of work experience, preferably in a regulated industry, e.g. medical device,
pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice
(GxP) environments.
Working knowledge of GxP regulations, CSV/CSA principles, including, but not limited to:
21 CFR Part 11, Annex 11, GAMP 5, Data Integrity, FDA QSR, ISO 13485, and/or EU
MDD/MDR, ICH 10.
Understanding and execution of Computer System Validation practices and processes in
the life science industry, including validation of SaaS, IaaS, PaaS. Demonstrated ability to
implement and improve CSV processes using SDLC best practices.
Skilled in handling end-to-end CSV projects implementation and application of project
controls, including familiarity with all project lifecycle phases from requirement gathering
through delivery, issues/risk management, change management, release management.
Preferred
Comfortable with Google Apps for Work applications and experience using SQL and data
analytics platforms.
Working knowledge of database management, software test tools, project management
methodology, change control, quality and system performance methods and metrics
Job tags
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