QA - Reviewer

Arbro Pharmaceuticals; Gurugram District; On-site; INR 600,000 - 800,000; Full time

Job summary

Arbro Pharmaceuticals in Haryana, India seeks a QA Reviewer to ensure data integrity and regulatory compliance across NABL ISO/IEC 17025, USFDA, GLP and GMP standards. You will review analytical data, COA, validation reports, and quality documentation to support audit readiness and CAPA management.

Responsibilities include auditing lab records, method validation review, document control, and training staff on SOPs and data integrity practices, with emphasis on ALCOA+ principles and continuous

Qualifications

• Knowledge of NABL (ISO/IEC 17025) requirements.
• Understanding of USFDA, GMP, GLP, and Data Integrity guidelines.
• Experience in analytical data review and documentation review.
• Knowledge of method validation and laboratory quality systems.
• Good understanding of CAPA, OOS, deviations, and audit management.
• Proficiency in MS Office and Laboratory Information Management Systems (LIMS).

Responsibilities

• Review analytical raw data, chromatograms, calculations, worksheets, and test reports.
• Verify compliance of laboratory records with SOPs, STPs, protocols, and regulatory requirements.
• Review Certificates of Analysis (COA), test reports, and validation reports before release.
• Ensure data integrity compliance (ALCOA+ principles).
• Participate in internal and external audits, customer audits, and regulatory inspections.
• Assist in NABL and USFDA inspections preparation and close audit observations.

Skills

Analytical data review

NABL ISO/IEC 17025

USFDA / GMP knowledge

Data integrity ALCOA+

Quality documentation review

LIMS proficiency

Tools

MS Office

LIMS

Job description

Job Summary

The QA Reviewer is responsible for reviewing analytical data, laboratory records, test reports, and quality documentation to ensure compliance with NABL (ISO/IEC 17025), USFDA, GLP, GMP, and internal quality requirements. The role involves ensuring data integrity, documentation compliance, method validation review, audit readiness, CAPA management, and quality system implementation. ISO/IEC 17025 laboratories are expected to maintain documented management systems, internal audits, corrective actions, and management reviews, which the QA Reviewer helps oversee.

Key Responsibilities

Quality Review & Documentation

• Review analytical raw data, chromatograms, calculations, worksheets, and test reports.
• Verify compliance of laboratory records with SOPs, STPs, protocols, and regulatory requirements.
• Review Certificates of Analysis (COA), test reports, and validation reports before release.
• Ensure data integrity compliance (ALCOA+ principles).

NABL & Regulatory Compliance

• Ensure compliance with NABL accreditation requirements and ISO/IEC 17025 standards.
• Support laboratory accreditation, surveillance audits, and reassessment activities.
• Review quality system documents, SOPs, forms, specifications, and protocols.
• Monitor compliance with laboratory quality management systems and internal audit requirements.

Method Validation & Verification

• Review method validation, method verification, method transfer, and stability study reports.
• Verify accuracy, precision, linearity, robustness, and other validation parameters.
• Ensure analytical methods comply with applicable regulatory guidelines.

Audit & Inspection Readiness

• Participate in internal audits, external audits, customer audits, and regulatory inspections.
• Assist in preparation for NABL and USFDA inspections.
• Review audit observations and ensure timely closure of corrective actions.

CAPA & Quality Systems

• Investigate deviations, OOS, OOT, incidents, and customer complaints.
• Prepare and review CAPA documentation and effectiveness checks.
• Track quality metrics and support continuous improvement initiatives.

Training & Compliance

• Conduct training on SOPs, quality systems, data integrity, and regulatory requirements.
• Ensure laboratory personnel comply with approved procedures and quality standards.

Required Skills

• Strong knowledge of NABL (ISO/IEC 17025) requirements.
• Understanding of USFDA, GMP, GLP, and Data Integrity guidelines.
• Experience in analytical data review and documentation review.
• Knowledge of method validation and laboratory quality systems.
• Good understanding of CAPA, OOS, deviations, and audit management.
• Proficiency in MS Office and Laboratory Information Management Systems (LIMS).