IQC Diploma Engineer Trainee, Dahanu, ACG Capsules

• Primary responsibilities

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

• Preparation of various reports
• Maintenance and verification of gauges to ensure proper calibration of these equipments 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 recommenders
• Calibration and verification of all equipment pertaining to the department.

• 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.
• Key Interfaces

External Interfaces

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

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