IQC Diploma Engineer Trainee, Dahanu, ACG Capsules

ACG World; Dahanu; On-site; INR 350,000 - 700,000; Full time

Job summary

ACG World in Dahanu, Maharashtra, seeks a QA/IQC lead to uphold GMP/GDP guidelines on the shop floor. You will review IQC sheets, provide decisions, and give online feedback to production for timely corrections.

You will conduct daily plant rounds, monitor CAPA, investigate defects to identify root causes, and drive corrective actions to prevent recurrence, ensuring FTR and compliance.

Responsibilities

• Review and provide decision based on the IQC sheet.
• Online feedback to production for correction.
• Daily plant rounds to ensure SOP, GDP and GMP compliance on the shop floor.
• Refer ZMIC for color or product change and guide IQC operators.
• Monitor CAPA during shifts.
• Investigate internal deviations to identify root causes and implement corrective/preventive actions.
• Track repeat failures and implement measures to avoid recurrence and ensure FTR.
• Line clearance for camera inspections and final inspection systems.
• Ensure daily document verification against defined standards.
• Prepare reports and maintain gauges/calibration records.
• Verify shade against master and Macbeth report.
• Verify daily profiles and online graphs.
• Periodically conduct process, product and systems audits.
• Provide data for annual product quality review & participate in APQR.
• Calibrate and verify all equipment pertaining to the department.

Skills

IQC knowledge

GMP/GDP awareness

Root cause analysis

Job description

• Review and provide decision based on the IQC sheet
• Online feedback to production for correction
• Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor
• Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same.
• Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same.
• Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR.
• Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System
• Ensuring document verification generated during shift on daily basis against defined standards

Primary responsibilities

Strategic and planning

Functional

Core:-

• Review and provide decision based on the IQC sheet
• Online feedback to production for correction
• Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor
• Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same.
• Monitoring CAPA during shifts.
• Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same.
• Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR.
• Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System
• Ensuring document verification generated during shift on daily basis against defined standards

Internal process

• Preparation of various reports
• Maintenance and verification of gauges to ensure proper calibration of these equipment’s on a regular basis in each shift
• Ensure verification of shade against master and Macbeth report
• Verification of daily profiles and online graphs
• Periodically conduct process, product and systems Audit.
• To provide data for annual product quality review & Participate in APQR and finalise the recommender's
• Calibration and verification of all equipment pertaining to the department.

People development

• Ensure proper manning and shift handling, shift activities.
• Effective training to the operators with evaluation for compliance.
• Effective manning to utilization of available sources.
• Key Result Areas
• KRA – In‑charge (Process monitoring parameter – RSD)
• Customer complaint investigation.
• Correct decision making within shift
• Awareness / Training to associates.

Internal Interfaces

External Interfaces

• Operations
• MSAT (TTT)
• Technical Services
• Scitech Centre
• Q&RA
• Customers
• External agencies / vendors
• Pin bar manufacturing unit

Technical Competency – T Compass

Leadership Competency – L Compass

Competency

Level

Competency

Work Level

Product and Process knowledge for capsule Manufacturing

4

Builder

3

Knowledge of quality management system

4

Integrator

3

Knowledge of pharma requirements

4

Innovator

3

Sound knowledge of statutory and regulatory requirements

4

People management skills

4

Analytical skills

4