Primary responsibilities -
Lead the inhouse QA QC team in day-to-day quality assurance and quality control activities. Prioritizes inspections and manpower based on project load.
Advanced knowledge of dimensional, visual, and functional inspection during sub-assembly and final assembly.
Develop, implement, and monitor quality systems in compliance with ISO, GMP, and regulatory standards. Develop the QAP for recent products
Review and approve QA/QC documentation (SOPs, Protocols, Test reports, validations).
Conduct internal audits and support external audits.
Ensure calibration, validation, and preventive maintenance of quality instruments.
Identifies potential failure points early in the process using FMEA and past NCR data. Drive root cause analysis, CAPA, and continuous improvement initiatives.
Coordinate with cross-functional teams (Production, RD, Engineering, Procurement) to resolve quality issues.
Guides IPQC inspectors and supports Production for in-line quality assurance.
Implementation of Kaizen 5S activities for continual improvement.
Takes ownership of process quality and product performance at each stage

Key Result Areas
Zero major NCs in customer and regulatory audits.
On-time closure of deviations, CAPA, and complaints.




Effective functioning of inhouse QA/QC lab as per defined standards.
Reduction in rework, rejection, and customer complaints.
Timely preparation of MIS and quality metrics.

Technical Competency

Competency

Competency

Knowledge of QA/QC systems, ISO, cGMP, and regulatory requirements

Data Analysis Tools

Leadership, team/Resource management, and training ability

Identify areas for improvement in processes and implement creative solutions.

Solid documentation, audit handling, and reporting skills

Planning and Execution

Hands-on experience in QC testing, calibration, and validation

Decision Making

Proficiency in root cause analysis, risk assessment, CAPA

Level of Education

BE/BTech in Engineering (Mechanical/ Industrial) or equivalent

BE/BTech in Engineering (Mechanical/ Industrial) or equivalent

Experience

5 7 years of experience in Inhouse in a regulated industry

5 10 years of experience in Inhouse Quality

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Lead Inhouse /in Process Quality Pune
🏢 ACG
📍 Pune