Quality Assurance Manager (USFDA Lab)

Arbro Pharmaceuticals; Gurugram District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Arbro Pharmaceuticals is seeking a QA leader to manage the complete Quality Assurance function for the laboratory, ensuring NABL and ISO/IEC 17025 compliance. You will develop SOPs, manuals and records, oversee audits, CAPAs and NCs, and drive quality improvements across departments.

The role requires hands-on QA management, robust documentation practices and strong stakeholder coordination to maintain laboratory excellence and regulatory readiness.

Qualifications

• NABL accreditation and ISO/IEC 17025 knowledge.
• Experience in Quality Management Systems (QMS).
• Hands-on in internal audits, CAPA, NC management and root cause analysis.

Responsibilities

• Manage and oversee the complete Quality Assurance function of the laboratory.
• Ensure compliance with NABL requirements and ISO/IEC 17025 standards.
• Develop, implement, review and maintain SOPs, quality manuals, procedures and quality records.

Skills

NABL accreditation

ISO 17025

QMS

Internal audits

CAPA

Root cause analysis

Documentation

Measurement uncertainty

Audit management

Stakeholder mgmt

Quality control

Job description

Role & responsibilities

• Manage and oversee the complete Quality Assurance function of the laboratory.
• Ensure compliance with NABL requirements and ISO/IEC 17025 standards.
• Develop, implement, review and maintain SOPs, quality manuals, procedures and quality records.
• Coordinate NABL assessments, internal audits, external audits and regulatory inspections.
• Monitor and close NCs, CAPA, observations and audit findings within defined timelines.
• Conduct and coordinate internal quality audits across various laboratory departments.
• Ensure proper control of documents, records, formats and quality-related documentation.
• Review and monitor quality indicators, deviations, complaints and corrective/preventive actions.
• Ensure proper implementation of method validation/verification, uncertainty of measurement and quality control procedures.
• Monitor proficiency testing (PT) / inter-laboratory comparison (ILC) activities and ensure timely corrective actions.
• Ensure proper handling and investigation of customer complaints, deviations and non-conformities.
• Coordinate with laboratory heads, technical teams and management for quality-related matters.
• Conduct training and awareness sessions for employees on quality systems, SOPs, NABL requirements and compliance.
• Maintain records related to equipment calibration, environmental monitoring, reference materials and quality control activities, wherever applicable.
• Prepare and present quality reports and MIS to senior management.
• Drive continuous improvement initiatives within the Quality Management System.

Required Skills & Competencies

• Strong knowledge of NABL accreditation and ISO/IEC 17025.
• Experience in Quality Management Systems (QMS).
• Hands-on experience in internal audits, CAPA, NC management and root cause analysis.
• Good understanding of method validation/verification and measurement uncertainty.
• Strong documentation and compliance skills.
• Excellent analytical, problem-solving and decision-making abilities.
• Good communication and stakeholder-management skills.
• Ability to independently handle NABL audits and quality-related inspections.