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.

- Valuable 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.

📌 Quality Assurance Manager (USFDA Lab) (Manesar)
🏢 Arbro Pharmaceuticals
📍 Manesar