Quality Control Analyst (Compliance & Quality)
Core
Ensure activities and deliverables are performed during the software development process as required by Suvoda procedures with little to no supervision; identify issues before release; review and approve SDLC and validation deliverables.
Role type
Quality Control Analyst (Compliance & Quality)
Builds
Suvoda software products and systems for clinical trial sponsors and site professionals
Domain
Clinical trial technology / Software Quality Assurance
Required skills
GxP regulations knowledge, SDLC validation, internal IT validation, vendor qualification, QMS documentation, deviation review, process improvement, risk-based judgment
Preferred skills
21 CFR Part 312, 21 CFR Part 11, Annex 11, ICH E6
Technologies
GxP, 21 CFR Part 312, 21 CFR Part 11, Annex 11, ICH E6
Responsibilities
Ensure activities and deliverables are performed during the software development process as required by Suvoda procedures with little to no supervision and/or support from members of the Quality Control team; Identify issues during the development of a Suvoda product (or delivery of a Suvoda service) before it is released and ensure that they are reported as per effective procedures; Review and approve SDLC and validation deliverables; Work with delivery teams, system owners or other stakeholders from the Compliance and Quality team to perform corrections and corrective actions, when necessary; Perform in process verifications in accordance with Suvoda procedures; Participate in the planning and execution of internal IT validation projects, including external party software validation and migration projects; Support the onboarding and qualification of 3rd Party Vendors, as necessary, in accordance with internal procedures; Identify and participate in process improvements projects, if and when required; Act as a Subject Matter Expert (SME) in areas where expertise has been established, if and when required; Author /review QMS documents, if and when required, with supervision and/or support from members of the Quality Control team; Review deviations from Suvoda's procedures with supervision and/or support from members of the Quality Control team.
Seniority
Mid-level, hands-on IC
