Compounding Executive – Injectables

KeyBiz Dashboards Pvt Ltd; Hyderabad; On-site; INR 350,000 - 550,000; Full time

Job summary

KeyBiz Dashboards Pvt Ltd in Hyderabad is seeking a hands-on Sterile Manufacturing Technician to execute and supervise compounding activities for sterile injectables, following approved BMRs, SOPs and manufacturing procedures.

You will operate and monitor vessels and associated equipment, perform CIP/SIP, ensure data integrity, maintain records, and coordinate with QA/QC to support audits and continuous improvement.

Qualifications

• Experience in sterile compounding and aseptic processing is preferred.
• Familiarity with cGMP, SOPs and batch manufacturing records (BMRs).
• Ability to maintain accurate real-time documentation and records.

Responsibilities

• Execute and supervise compounding activities for sterile injectables per approved BMRs/SOPs.
• Operate and monitor manufacturing vessels and associated equipment.
• Perform CIP and SIP activities and ensure data integrity in manufacturing records.
• Coordinate with QA, QC and cross-functional teams to ensure smooth batch execution.

Skills

Compounding

Aseptic processing

cGMP compliance

Equipment operation

Documentation

QA coordination

Tools

pH meters

Conductivity meters

CIP/SIP systems

Weighing balances

Filtration vessels

Job description

• Execute and supervise compounding activities for sterile injectable products as per approved BMRs, SOPs, and manufacturing procedures.
• Perform dispensing/charging of raw materials and excipients as per approved manufacturing instructions.
• Operate and monitor manufacturing vessels, compounding tanks, mixing systems, filtration systems, and associated equipment.
• Perform and monitor CIP and SIP activities of manufacturing vessels and associated systems.
• Carry out aseptic filtration and filtration-related activities as per approved procedures.
• Monitor critical process parameters such as temperature, pressure, pH, conductivity, mixing time, and other applicable parameters.
• Perform required in-process checks during compounding and filtration operations.
• Ensure proper cleaning, sanitization, and maintenance of the compounding and filtration areas.
• Maintain Batch Manufacturing Records (BMRs), equipment logbooks, cleaning records, and other GMP documentation accurately and in real time.
• Ensure compliance with cGMP, SOPs, safety procedures, and contamination-control practices.
• Handle and operate equipment such as weighing balances, pH meters, conductivity meters, filtration vessels, compounding vessels, CIP/SIP systems, and related manufacturing equipment.
• Coordinate with QA, QC, Warehouse, Engineering, and other cross-functional teams for smooth execution of manufacturing activities.
• Support equipment calibration, qualification, validation, and preventive-maintenance activities.
• Report and support investigation of deviations, incidents, process abnormalities, and equipment-related issues.
• Ensure proper line clearance, area readiness, and equipment readiness before commencement of batches.
• Support media fill and other aseptic manufacturing activities, wherever applicable.
• Follow good documentation practices and ensure data integrity in all manufacturing records.
• Participate in internal and regulatory audit/inspection activities as required.
• Follow all company EHS and safety requirements.
• Contribute to continuous improvement, productivity enhancement, and reduction of manufacturing deviations.