SR. EXECUTIVE – PRODUCTION | RAPID KITS / IVD

• 2–5 years of relevant experience in IVD / Diagnostic Reagent / Rapid Kit / ELISA manufacturing .
• Hands-on experience in:
  • Reagent buffer preparation
  • Gold conjugation
  • NCM coating
  • Diagnostic reagent manufacturing
  • Production troubleshooting
• Experience in production planning and scheduling.
• Understanding of raw-material planning and inventory management.
• Exposure to medical-device quality and production guidelines.
• Ability to lead and coordinate production staff.
• Strong focus on quality, productivity, safety and timely production.

1. Diagnostic Reagent Manufacturing

• Execute production of diagnostic reagents, Rapid Kits and ELISA products as per approved SOPs and manufacturing guidelines.
• Ensure production activities are carried out according to defined process parameters and specifications.
• Maintain batch-wise production records and documentation.
• Ensure consistency and reproducibility of manufacturing processes.

2. Reagent & Process Manufacturing

Hands-on exposure to the following is highly important:

• Reagent buffer preparation
• Gold conjugation
• Nitrocellulose Membrane (NCM) coating
• Reagent preparation and processing
• Troubleshooting of manufacturing/process-related issues
• Optimization of process parameters to achieve required product specifications

3. Production Planning & Scheduling

• Prepare and execute daily/weekly production plans.
• Schedule manufacturing activities according to customer/business requirements.
• Coordinate with Quality, R&D, Stores and other functions to ensure timely production.
• Monitor production progress against planned targets.
• Identify bottlenecks and take corrective actions.

4. Raw Material Planning & Inventory

• Plan raw-material requirements based on production schedules.
• Coordinate with Stores/Purchase for timely availability of materials.
• Monitor inventory levels.
• Avoid production delays due to material shortages.
• Ensure proper utilization and control of raw materials.
• Maintain appropriate production and inventory records.

5. Process Troubleshooting & Improvement

• Identify and troubleshoot production/process deviations.
• Investigate recurring manufacturing issues.
• Work with Quality/R&D teams to identify root causes.
• Implement process improvements wherever required.
• Improve production efficiency, yield and consistency.
• Support cost-effective manufacturing initiatives.

6. Quality & Medical Device Compliance

• Ensure manufacturing activities comply with applicable medical-device and IVD quality requirements .
• Follow approved SOPs, batch manufacturing records and work instructions.
• Maintain proper documentation and traceability.
• Ensure products meet defined quality specifications.
• Coordinate with Quality Assurance/Quality Control teams for deviations, investigations and corrective actions.

7. Equipment, Health & Safety

• Ensure safe operation of production equipment.
• Follow plant health, safety and environmental requirements.
• Ensure equipment is maintained and used as per defined procedures.
• Report equipment/process abnormalities promptly.
• Support preventive maintenance activities where required.

8. Team Management & Coordination

• Guide and supervise production staff/operators.
• Allocate manpower according to production requirements.
• Monitor team productivity and adherence to SOPs.
• Train team members on production processes and safety practices.
• Coordinate with cross-functional teams to achieve production targets.
• Maintain discipline and a quality-focused production culture.

9. Production Documentation & Reporting

• Maintain production records, batch records and process documentation.
• Prepare production MIS/reports.
• Track production output, yield, rejection and productivity.
• Report deviations and production issues to management.
• Ensure all documentation is completed accurately and on time.