Gel Room In charge

Job Summary:

The Gel Room Head of Department (HOD) will be responsible for managing and controlling all gel room operations related to the preparation, processing, and transfer of gelatin mass used in hard capsule manufacturing. The role ensures that all gelatin batches meet defined quality, productivity, and compliance standards. The position requires strong technical expertise in gelatin processing, leadership skills, and in-depth knowledge of cGMP and regulatory requirements.

Key Responsibilities:

1. Gel Preparation & Process Control

• Plan and oversee the complete process of gelatin solution preparation in line with approved formulations and production schedules.
• Monitor key process parameters (temperature, viscosity, pH, moisture content, mixing time) to ensure consistent batch quality.
• Ensure proper weighing, charging, and mixing of raw materials — gelatin, colorants, titanium dioxide, and plasticizers.
• Maintain validated process parameters and ensure adherence to batch manufacturing records (BMR).
• Supervise the maturation, filtration, and transfer of gelatin to encapsulation machines.

2. Quality, Compliance & Documentation

• Ensure all gel room activities comply with cGMP, FDA, MHRA, WHO, and local regulatory guidelines.
• Review and approve BMRs, SOPs, and process validation protocols.
• Coordinate with Quality Assurance (QA) for in-process checks, line clearance, and deviation handling.
• Initiate and lead investigations of deviations, OOS (Out of Specification), or non-conformance incidents and implement CAPAs.
• Maintain proper documentation for traceability and audit readiness.

3. Equipment & Maintenance

• Oversee operation, cleaning, and maintenance of all gel room equipment such as gelatin melting tanks, vacuum systems, transfer pumps, and filtration units.
• Ensure timely preventive maintenance and calibration in coordination with the Engineering department.
• Monitor equipment performance and recommend process or equipment upgrades for efficiency improvement.
• Ensure equipment qualification (IQ/OQ/PQ) and maintain related documentation.

4. Manpower & Team Management

• Lead, train, and motivate a team of gel room operators, technicians, and supervisors.
• Allocate manpower efficiently to meet production schedules.
• Conduct regular training sessions on SOPs, GMP, safety, hygiene, and process improvement.
• Foster a culture of teamwork, ownership, and continuous learning.

5. Safety & Environmental Compliance

• Ensure adherence to safety standards and use of proper PPE by all team members.
• Maintain cleanliness and hygiene of the gel room in compliance with ISO and EHS (Environment, Health, Safety) norms.
• Manage waste disposal as per environmental and company policies.

6. Continuous Improvement & Reporting

• Monitor batch yield, gelatin consumption, and wastage, and take corrective measures to optimize cost and efficiency.
• Implement lean manufacturing, 5S, and Kaizen initiatives for productivity enhancement.
• Prepare and present daily, weekly, and monthly reports on production, quality, and downtime analysis.
• Collaborate with R&D and Process Validation teams for new product introduction or process improvement projects.

Qualifications & Experience:

• Education:

• B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry) / B.E. or Diploma in Chemical / Mechanical Engineering.

• Experience:

• 10-15 years in hard gelatin capsule manufacturing, with a minimum of 3 years in a supervisory or managerial role in the gel room.

• Technical Skills:

• In-depth knowledge of gelatin properties, preparation, and handling.
• Familiarity with encapsulation process requirements for hard gelatin capsules.
• Understanding of cGMP, ISO, and regulatory audit requirements.
• Proficiency in documentation and ERP systems (SAP preferred).

Package- Up to 6lpa

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