Quality Control Analyst - Compliance & Quality

Suvoda is a global clinical trial technology company shaping digital experiences that enable clinical trial sponsor and site professionals to take full command over the inherent logistical complexity behind mission-critical and time-sensitive patient interactions in life-sustaining studies for therapeutic areas such as oncology, central nervous system, and rare disease.

Supporting clinical trials means supporting unique experiments that are inherently complex, high-stakes, and dynamic. It is imperative that Suvoda staff working with clients, end-users, or the systems that client and end-users interact with understand the clinical trial industry, regulations, Suvoda’s software products and processes, and especially the specificities of the unique trial in question before taking any actions they may alter the data of the system in question.

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;
• 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:

• 1-3+ years of experience in a similar role;
• 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.

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