04 Nov
|
ITC_Labs
|
Panchkula
04 Nov
ITC_Labs
Panchkula
: QMS & Data Reviewer – Quality Assurance
Job Title: QMS & Data Reviewer – Quality Assurance (QA)
Department: Quality Assurance Reporting To: QA Manager / Quality Head
Job Summary The QMS & Data Reviewer is responsible for reviewing, monitoring, and maintaining the Quality Management System (QMS) and ensuring the accuracy, completeness, and compliance of quality-related data and documentation. The role involves reviewing quality records, monitoring compliance with established procedures, identifying discrepancies, and supporting continuous improvement activities to ensure adherence to company standards and applicable regulatory requirements.
Key Roles & Responsibilities
1. QMS Documentation Review
- Review and maintain Quality Management System (QMS) documents.
- Verify SOPs, work instructions, policies, and quality records.
- Ensure documents are accurate, updated, approved, and properly controlled.
- Monitor document revision history and document control processes.
1. Data Review & Verification
- Review quality-related data for accuracy, completeness, and consistency.
- Verify data entries, reports, checklists, and records.
- Identify data discrepancies, errors, missing information, and deviations.
- Ensure data integrity and compliance with established procedures.
1. Quality Compliance
- Ensure compliance with internal QMS requirements and applicable regulatory standards.
- Review records to ensure proper documentation and traceability.
- Identify non-conformities and coordinate corrective actions.
- Support internal and external quality audits.
1. CAPA & Deviation
- Review Corrective and Preventive Action (CAPA) records.
- Monitor deviations, non-conformities, and quality incidents.
- Track CAPA implementation and closure status.
- Verify the effectiveness of corrective and preventive actions.
1. Reporting & Analysis
- Prepare daily, weekly, and monthly quality reports.
- Analyze quality trends and identify recurring issues.
- Maintain quality performance records and dashboards.
- Escalate critical discrepancies to the QA Manager.
1. Continuous Improvement
- Identify opportunities to improve documentation and data management processes.
- Support process improvement initiatives.
- Ensure timely closure of documentation gaps and quality observations.
Required Skills & Competencies
- Good knowledge of Quality Management Systems (QMS).
- Strong documentation and data review skills.
- Knowledge of SOPs, CAPA, deviations, and non-conformities.
- Understanding of data integrity principles (ALCOA+).
- Positive analytical and problem-solving abilities.
- Proficiency in MS Excel, Word, and PowerPoint.
- Strong attention to detail and accuracy.
- Good communication and coordination skills.
Educational Qualification
- Bachelor's degree in a relevant discipline.
- Additional certification or training in Quality Assurance / Quality Management is preferred.
Experience
- 1–7 years of experience in Quality Assurance, QMS documentation, data review, or quality compliance.
Key Performance Indicators (KPIs)
- Accuracy and completeness of reviewed data.
- Timely review and closure of quality records.
- QMS documentation compliance.
- Number of documentation errors and discrepancies identified.
- CAPA and deviation tracking effectiveness.
- Audit readiness and compliance performance.
Pay: ₹500,000.00 - ₹600,000.00 per year
Benefits
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
📌 Sr. Executive - QMS & DATA REVIEWER Quality Assurance (Panchkula)
🏢 ITC_Labs
📍 Panchkula