Reviews and approves clinical drug product batch records, in-process quality control data, change controls, deviations and test results for timely disposition of products for human clinical use.
May 22, 2021
Demonstrated experience with writing and executing SQL queries or analytical report creation skills with strong Excel knowledge as basic fundamentals of database testing.
May 26, 2021
Participates in new product scale-up, process optimization, technology transfer and process verification and validation activities.
May 27, 2021
Develop manual and automated tests by analyzing user stories, participating in design reviews and collaborating with the Developers, Product Owners, and Business Analysts.
June 15, 2021
Act in a project lead and/or business analyst capacity for assigned projects to include performing project documentation, tracking and communicating project status of deliverables, risk and issue analysis and problem resolution for work products assigned.
July 24, 2021
Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820, GAMP), and IT Security Standards lab systems, infrastructure upgrades, ERP, and manufacturing solutions.
July 31, 2021
Assists in supporting software quality control and assurance activities by developing and maintaining less complex workflow templates and other best practice activities for the organization.
August 04, 2021