Location: Vadodara, Gujarat.

Experience: 15 years.

Key Responsibilities:

Quality Systems Implementation & Compliance:

- Implementation and maintenance of procedures related to:

1. Identification and traceability of finished products.

2. Inspection and testing of finished bottles and vials.

3. Inspection and test status control.

4. Control of non-conforming products.

5. Corrective and Preventive Action (CAPA).

6. Handling, storage, packaging, preservation, and delivery of finished bottles and vials.

7. Review and continuous improvement of the Quality Management System.

- Ensure full compliance with:

1. GMP (Good Manufacturing Practices).

2. QMS (Quality Management System).

3. ENMS (Energy Management System).

4. FSMS (Food Safety Management System, if applicable).

5. ISO standards.

6. EMS (Environmental Management System).

7. OHSAS / Occupational Health & Safety standards.

- Lead internal and external audits.

- Maintain documentation as per regulatory requirements.

Raw Material & Batch Quality Control:

- Inspection and approval of:

1. Silica sand.

2. Soda ash.

3. Limestone.

4. Dolomite.

5. Cullet.

6. Additives and colorants.

- Monitor batch composition accuracy and homogeneity.

- Conduct chemical analysis and maintain test records.

- Coordinate vendor quality audits and supplier improvement programs.

In-Process & Cold End Quality Control:

- Overall Responsibility of Cold End Department.

- Supervise inspection activities at Cold End.

- Monitor and control:

1. Dimensional accuracy.

2. Weight consistency.

3. Wall thickness.

4. Finish and neck dimensions.

5. Visual defects (checks, cracks, stones, blisters, inclusions, seeds, scratches).

- Ensure proper functioning of inspection machines:

1. Automatic inspection machines.

2. Camera-based defect detection systems.

3. Leak testing equipment.

4. Vertical load testing machines.

5. Thermal shock testing systems.

- Monitor annealing lehr temperature profile and stress levels.

- Conduct strain testing using polariscopes.

- Maintain AQL levels and rejection analysis.

Finished Product Inspection & Testing:

- Ensure proper identification and traceability of finished bottles and vials.

- Maintain inspection and test status of each batch.

- Conduct:

1. Compression testing.

2. Internal pressure testing.

3. Impact resistance testing.

4. Thermal shock resistance testing.

- Approve/reject finished goods before dispatch.

- Ensure proper packaging, preservation, and delivery as per customer and regulatory requirements.

Control of Non-Conforming Products:

- Identify and segregate non-conforming products.

- Ensure proper labeling and documentation.

- Conduct Root Cause Analysis (RCA).

- Implement Corrective and Preventive Actions (CAPA).

- Monitor effectiveness of corrective measures.

Customer Complaint Handling (B+C Sort):

- Overall responsibility for customer complaint resolution.

- Handle B+C Sort activities effectively.

- Conduct complaint investigation and defect analysis.

- Coordinate sorting, inspection, and corrective actions.

- Maintain complaint trend analysis reports.

- Reduce repeat complaints through systemic improvement.

Calibration & Laboratory Management:

- Ensure calibration of inspection and measuring instruments.

- Maintain calibration records and schedules.

- Oversee laboratory testing activities.

- Ensure all instruments comply with standard requirements.

- Maintain documentation and test reports.

Training & Records Management:

- Identify training needs for department members.

- Provide and maintain records of training.

- Conduct regular skill development and GMP awareness sessions.

- Ensure competency evaluation of inspectors and technicians.

Process Improvement & Cost of Quality:

- Monitor:

1. Rejection %.

2. Customer complaint rate.

3. First-pass yield.

4. Cost of poor quality (COPQ).

- Drive Six Sigma / Lean initiatives.

- Improve production yield and reduce breakage.