Posted:1 week ago|
Platform:
On-site
Full Time
Quality Assurance Manager
Azis Labs · Indore, Madhya Pradesh, India (On-site)
Azis Labs, a leading ISO/IEC 17025-accredited, FDA- and MOEF-approved multidisciplinary laboratory, is looking for a Quality Assurance (QA) Manager to lead and strengthen our quality management systems.
Location: Pithampur
🔍 Key Responsibilities:
• Oversee and maintain the laboratory’s QMS as per ISO/IEC 17025:2017.
• Lead document control, quality manuals, SOPs, and records.
• Coordinate with NABL assessors /FDA auditors during assessments.
• Train and guide teams on compliance, metrology, and method verification.
• Ensure strict adherence to NABL and regulatory body requirements.
• Coordinate and conduct internal audits, manage corrective and preventive actions (CAPA), and oversee closure of non-conformities.
• Monitor and report quality indicators, trends, and key performance metrics.
• Conduct root cause analysis (RCA) for deviations and non-conformities.
• Lead management review meetings (MRMs) and prepare required reports.
• Coordinate with Technical Managers and Section Heads for method validation/verification and ensure compliance with technical requirements.
• Liaise with external auditors (NABL, FSSAI, FDA, etc.) and ensure audit readiness.
• Maintain and control equipment calibration and maintenance records.
• Oversee proficiency testing (PT)/inter-laboratory comparisons (ILC) planning and result analysis.
• Conduct quality training sessions for laboratory personnel.
• Ensure sample traceability, integrity, and confidentiality throughout the testing process.
• Facilitate risk assessments, continuous improvement, and client feedback analysis.
✅ Qualifications & Skills:
• Minimum 5 years’ experience in a NABL-accredited lab QA role.
• In-depth knowledge of ISO/IEC 17025:2017, audit processes, and technical standards.
• Knowledge on FDA/ MOEF and other regulatory audits is helpful but not mandatory.
• Strong documentation and communication skills.
• Hands-on experience with non-conformance management and root cause analysis.
• Testing lab experience is mandatory.
✨ Why Join Us?
• Competitive salary and benefits
• Growth-focused, dynamic work environment
• Work with a passionate, high-performing technical team
Azis Labs
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