Senior Analyst, Digital Core

This is a fully remote position, open to applicants in India.

📋 Description

• Ensure early involvement of EQ in the design and development of applications and infrastructure to integrate automated and preventive controls from the outset.

• Take ownership and lead the comprehensive quality process and strategy, offering compliance guidance for applications and the supporting infrastructure.

• Provide strategic direction and operational assistance to project teams while managing the execution of TQ tasks to align with project plans, objectives, and timelines.

• Develop and contribute to strategies for the qualification and validation of new and emerging technologies.

• Maintain readiness for inspections by health authorities, internal and external audits, and periodic reviews; participate in audits and approve action plans and closures for non-conformities.

• Assist in incident management, CAPA, and the resolution of non-conformities for the systems within scope.

• Review and approve validation documentation and authorize releases to production, including Compliance Plans, User Requirements/User Stories, System Tests, UAT, Traceability Matrices, and Compliance Reports.

• Actively monitor systems and processes to ensure alignment with SOPs and industry guidelines; collaborate with the EQ Manager to oversee project costs, schedules, resources, and quality.

• Collaborate with cross-functional team members to implement compliant solutions, set expectations, communicate feasibility and timeframes, and identify quality risks.

• Lead and mentor team members: provide quality guidance, apply risk-based validation methodologies, manage consultants and vendors, foster future leaders, and ensure resource availability for initiatives.

⛳️ Requirements

• A Bachelor’s degree or equivalent in Computer Science, Information Systems, Business Administration, Science, Engineering, or a related field is required.

• 2-4 years of progressive experience in the pharmaceutical, medical device, or biotech industries, with direct involvement in Computerized System Validation activities.

• Capability to work independently with a high degree of self-management across a diverse range of tasks and initiatives related to quality and validation.

• Solutions-oriented, seeking innovative ways to achieve goals while providing pragmatic advice to ensure compliance in a cost-effective and risk-based manner.

• Comprehensive knowledge of cGMP regulations associated with CSV, including 21 CFR Part 11, Part 210, Part 211, and Part 820.

• Experience validating Testing Management tools such as qTest and Jira with Xray, as well as security tools like Identity and Access Management and OT security tools.

• Background in a fast-paced CICD environment with tools like Jenkins, GitHub, Bitbucket, and Artifactory.

• Proficiency in the English language, both written and spoken, is required.

🏝️ Benefits

• Inclusive work environment

• Health insurance

• Professional development opportunities