Quality Engineer- CSV:

DUTIES & RESPONSIBILITIES:

- Collaborate with management, global CSV teams, and business stakeholders to understand requirements, communicate project status, and deliver assigned validation responsibilities within agreed timelines.
- Perform GxP assessments to determine system applicability and associated validation requirements.
- Apply 21 CFR Part 11 and EU Annex 11 requirements, MHRA Data Integrity Guidance, and ALCOA+ principles throughout computer system validation activities.
- Apply GAMP 5 guidelines when planning and executing computer system validation activities.
- Perform risk-based validation and complete system risk assessments using Failure Mode and Effects Analysis (FMEA).
- Prepare, review, and approve validation documentation, including validation plans, risk assessments, test protocols, traceability matrices, validation reports, and associated deliverables.
- Execute computer system validation activities in accordance with the Software Development Life Cycle (SDLC) methodology.
- Support risk-based AI validation for intended GxP use, covering data quality, model performance, reliable outputs, human oversight, ongoing monitoring, and change control.
- Perform validation of GAMP Category 4 and Category 5 software, as applicable to assigned projects.
- Perform eQMS enhancements and workflow validation to ensure intended functionality, data integrity, and compliance with approved requirements.
- Ability to use AI-enabled tools, Microsoft Copilot to streamline validation activities
- Use HP ALM to manage validation requirements, test execution, defects, and traceability.
- Perform IT Quality reviews of change controls and incident management records as part of ongoing validated system maintenance.




- Conduct periodic reviews of all validated systems to assess their continued validated state.
- Participate in Kaizen initiatives to drive continuous improvement in validation processes, efficiency, and quality.
- Execute decommissioning and retirement activities for legacy computer systems.

QUALIFICATIONS A bachelors degree or higher in engineering or a scientific discipline, preferably Pharmacy/Biologics, Computer Science and Engineering, or Instrumentation.

- 3–7 years of relevant experience in computer system validation, instrument validation, and quality systems.
- Understanding of Quality Management System (QMS) processes, including incident management, corrective and preventive action (CAPA), and deviation management.
- Understanding of quality principles, regulatory compliance, and audit readiness requirements within the pharmaceutical and healthcare sectors.
- Familiarity with Azure DevOps (ADO) for backlog management, user stories, sprint activities, defect tracking, requirements traceability, and project reporting.
- Certification in Microsoft Copilot or other AI-enabled productivity tools is preferred.
- Knowledge of ISO 9001:2026 Quality Management System requirements (mandatory)
- Knowledge of ISO 13485:2016 MD Quality management systems — Requirements for regulatory purposes (good to have)

Other skills required:

- Excellent written and oral communication
- Team player who is easy to work with
- Combination of big picture understanding and vision with outstanding attention to detail
- Problem solver with strong analytical skills – comfortable with both theoretical and practical issues
- Able to work independently and within a team.
- Strong ability to document work.
- Able to prioritize tasks effectively and to communicate roadblocks promptly to management within a fast-paced setting where project / team priorities may shift.

📌 Quality Engineer (Pune)
🏢 Ecolab Global Services
📍 Pune