Project Management - Executive @ Kazipalli

Hetero; Hyderabad; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Hetero is seeking a process transfer specialist to support technology transfer activities from R&D to pilot plant and commercial manufacturing. You will assist in scale-up, optimization, and validation for API products, coordinating with multiple teams to resolve issues and ensure robust documentation and reports.

The role involves supporting process validation, review of batch records, and driving improvements, while ensuring GMP and regulatory compliance across manufacturing operations.

Responsabilités

• Assist in process scale-up, process optimization, and validation activities for API products.
• Coordinate with Production, QA, QC, Engineering, and R&D teams to resolve process-related issues.
• Prepare and review technology transfer documents, process descriptions, batch manufacturing procedures, and technical reports.
• Support process troubleshooting during manufacturing and recommend corrective actions in coordination with relevant departments.
• Participate in process validation, exhibit batches, engineering batches, and process improvement activities.
• Review batch manufacturing records and investigate process deviations in coordination with QA and Production.
• Ensure compliance with GMP, SOPs, safety guidelines, and applicable regulatory requirements.
• Support yield improvement, cycle-time reduction, solvent recovery, and cost-optimization initiatives.
• Maintain technical documentation and provide support during internal, customer, and regulatory audits.

Description du poste

Role & responsibilities

Support technology transfer activities from R&D to pilot plant and commercial manufacturing.

• Assist in process scale-up, process optimization, and validation activities for API products.
• Coordinate with Production, QA, QC, Engineering, and R&D teams to resolve process-related issues.
• Prepare and review technology transfer documents, process descriptions, batch manufacturing procedures, and technical reports.
• Support process troubleshooting during manufacturing and recommend corrective actions in coordination with relevant departments.
• Participate in process validation, exhibit batches, engineering batches, and process improvement activities.
• Review batch manufacturing records and investigate process deviations in coordination with QA and Production.
• Ensure compliance with GMP, SOPs, safety guidelines, and applicable regulatory requirements.
• Support yield improvement, cycle-time reduction, solvent recovery, and cost-optimization initiatives.
• Maintain technical documentation and provide support during internal, customer, and regulatory audits.