Lead Inhouse /In Process Quality

ACG World; Satara; On-site; INR 900,000 - 1,300,000; Full time

Job summary

ACG World in Satara, Maharashtra, invites an experienced QA/QC Lead to head the in-house QA & QC team, ensuring strict adherence to ISO and GMP standards across sub-assembly and final assembly.

You will drive CAPA, FMEA, internal and external audits, and continuous improvement through Kaizen and 5S, while coordinating with Production, R&D, Engineering, and Procurement to uphold product quality at every stage.

Qualifications

• BE/BTech in Mechanical or Industrial engineering required.
• 5–10 years in in-house Quality in a regulated industry.
• Experience with ISO, cGMP, audits, and QA documentation.
• Proven track record in CAPA, FMEA, and continuous improvement.

Responsibilities

• Lead QA/QC team in daily quality assurance and control.
• Prioritize inspections and manpower based on project load.
• Develop and monitor ISO/cGMP-compliant quality systems.
• Review QA/QC docs: SOPs, protocols, test reports.
• Conduct internal audits and support external audits.
• Ensure calibration, validation, and preventive maintenance.
• Lead root cause analysis, CAPA, and continuous improvement.
• Coordinate with Production, R&D, Engineering, Procurement.
• Guide IPQC inspectors and support in-line QA.
• Implement Kaizen & 5S for continual improvement.
• Takes ownership of process quality and product performance at each stage.

Skills

Quality management

ISO & cGMP knowledge

Root cause analysis

CAPA

Kaizen & 5S

Calibration & validation

Leadership

Documentation & audits

Data analysis

Education

BE/BTech (Mechanical/ Industrial)

Tools

QA/QC Tools

Statistical analysis (Minitab/Excel)

Job description

• 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 new 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, R&D, 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

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 new 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, R&D, 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 innovative solutions.
• Strong 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