Position Title : Lead Inhouse /In Process Quality
Job Objective :
To lead the In process / In house Quality Assurance & Quality Control function by ensuring compliance with regulatory standards, implementing robust quality systems, and driving continuous improvement in processes, documentation, and product quality.
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
- Understands internal customer (Production/QA) needs and provides timely feedback
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.
Competency:
- Knowledge of QA/QC systems, ISO, cGMP, and regulatory requirements
- Leadership, team/Resource management, and training ability
- Strong documentation, audit handling, and reporting skills
- Hands-on experience in QC testing, calibration, and validation
- Proficiency in root cause analysis, risk assessment, CAPA
- Data Analysis Tools
- Identify areas for improvement in processes and implement innovative solutions.
- Planning and Execution
- Decision Making
Level of Education -
BE/BTech in Engineering (Mechanical/ Industrial) or equivalent
Experience -
experience in Inhouse Quality