NovintiX
Website:
novintix.com
Job details:
Job Title: Quality Engineer (NC/CAPA)
Location: India – Coimbatore
Summary
Own and drive Nonconformance (NC) and Corrective and Preventive Action (CAPA) activities from initiation through closure and effectiveness review in a regulated GMP environment. Lead investigations, assess risk and the need for CAPA, create and assign supporting records, and ensure audit readiness and compliance with company policies and applicable regulations.
Essential Duties and Responsibilities
- Initiate, own, and complete NC/CAPA investigations for failures to meet specified process or product requirements, including deviations from established processes, specifications, written procedures, controls, tests, or examinations that may affect a product’s identity, purity, efficacy, strength, quality, or potency, or the validated state of a product or process.
- Ensure adherence to the NC/CAPA process, coordinate contributors and action owners, and monitor/contribute to timely completion of investigations and actions.
- Lead and document NC/CAPA investigations, including risk assessments.
- Document participants in each risk assessment.
- Ensure action plans are documented and implemented.
- Determine whether effectiveness plans are required, ensure applicable plans are implemented, and ensure required verification or validation activities are completed.
- Identify the Subject Matter Experts (SMEs) required to contribute to or own deliverables associated with the NC/CAPA; assign NC/CAPA action owners and appropriate reviewers and approvers; and coordinate cross-functionally with Quality, Manufacturing, R&D, Supply Chain, Procurement, and other stakeholders to implement containment, corrective, and preventive actions.
- Include the qualified person in decisions where required by applicable regulations.
- Ensure NC/CAPA records adhere to Good Documentation Practices (GDP); create, route, track, and close records in the QMS; maintain product information and traceability of decisions and actions; and edit containment records as necessary, provided the related NC/CAPA records are not in completed or closed status.
- Communicate status, risks, and outcomes of investigations and CAPAs to key stakeholders and management in a timely manner.
- Ensure NC/CAPA processes and records are audit-ready and compliant with company policies, procedures, cGMP, and applicable regulatory requirements.
- Participate in continuous improvement activities for the NC/CAPA process, including metrics collection and trend analysis.
- Provide support and guidance on NC/CAPA process expectations and use of the QMS as needed.
- Make routine investigation and record-management decisions independently within approved procedures.
- Obtain QA approval for formal conclusions, risk assessments, CAPA plans, extensions, disposition, and closure.
- Involve the Qualified Person where batch certification, release, or regulatory commitments may be affected.
- Escalate resource commitments, ownership conflicts, significant residual risk, or procedural exceptions to functional management or governance, as applicable.
Profile and Minimum Qualifications
- Proven ability to perform independent work that requires attention to detail, accuracy, and sound scientific or technical judgment.
- Experience in conducting investigations, root cause analysis, and risk assessments in a regulated environment.
- Aptitude to comprehend, analyze, and interpret process and system information, technical procedures, reports, and regulations to make GMP-compliant decisions.
- Strong interpersonal, written, and oral communication skills; adept at stakeholder engagement and active listening.
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Proficient in written and verbal English.
Preferred Qualifications
- Experience with QMS software is highly desirable.
- Knowledge of Quality Systems processes inclusive of cGMP and FDA regulations preferred.
- Demonstrated ability to collaborate across multifunctional teams and build relationships with process owners and business partners.
- Demonstrated proactive ownership, strong accountability, and solid organizational skills.
- At least two years of relevant industry experience preferred.
Desired Competencies
- Root cause analysis tools (e.g., 5 Whys, Fishbone/Ishikawa, FMEA)
- Risk-based decision making
- Project management and prioritization
- Audit readiness mindset and experience supporting internal/external audits
- Continuous improvement orientation
Key Performance Indicators
- Percentage of NC and CAPA investigations completed within target timelines.
- Percentage of CAPAs confirmed effective through effectiveness review.
- Trend in repeat nonconformances related to closed CAPAs.
- Number and trend of audit findings related to the NC/CAPA process.
- Quality of documentation, measured by completeness, compliance, and required rework.
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