Senior Quality Control Analyst

Role Overview

• 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
• Release Suvoda products and systems through the various phases of development
• 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

Requirements

• Bachelor’s degree
• Knowledge of GxP regulations, such as 21 CFR Part 312, Part 11, Annex 11 and ICH E6, preferred
• High-achieving personality
• Desire to learn and grow
• Strong work ethic
• Sense of ownership
• Proactive attitude
• Time management and organization skills
• Attention to detail
• Risk-based judgment
• Good communication and technical writing capabilities

Tech Stack

• SDLC

Benefits

• The flexibility: Suvoda creates the perfect environment for people to integrate their work and life, by offering flexible working hours
• The growth and innovation: As part of a growing team, you’ll have lots of opportunities for career development and be exposed to the latest technologies due to our focus on innovation
• The office: Our newly renovated, modern office space is located in the city center and is equipped with comfortable work spaces, collaborative gathering areas and modern technology that easily connects you to all of our global offices
• The benefits: You’ll have access to a robust benefits package, meal tickets, a top subscription from Romania’s top healthcare provider, a fitness stipend, and competitive salaries with bonus plans
• The industry: By working in clinical trials, you’ll be part of a challenging and rewarding industry that will allow you to develop your skills quickly while doing your part to change the world!