Senior Officer, Manufacturing Injectables

Amneal Pharmaceuticals LLC; India; On-site; INR 650,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, Gujarat, India, is seeking a trained professional to support sterile injectable manufacturing within a regulated GMP environment. You will operate equipment, handle materials, and contribute to compounding and filling processes while ensuring sterility and quality.

The role requires maintaining batch records, adherence to SOPs, and active participation in process improvements to enhance quality and efficiency in manufacturing operations.

Qualifications

• B. Pharm / Master Degree (MS/MA) or MSc preferred.
• 2+ years experience in aseptic injectable manufacturing.
• Experience working in GMP/cGMP environments.

Responsibilities

• Operate and monitor injectable manufacturing equipment per approved procedures.
• Handle raw materials, intermediates, and finished injectables maintaining sterility.
• Perform compounding, filling and related processes per batch records.
• Maintain accurate batch documentation and records per SOPs.

Skills

Aseptic Manufacturing

Contamination Control

GDP / Documentation

Regulatory Label Compliance

Safety & Hygiene

Sterility Assurance

Data Integrity

Manufacturing Process Monitoring

Material Handling

Education

B. Pharm / Master Degree (MS/MA) M. Sc. - Preferred

Job description

Ahmedabad City, Gujarat, India

Job Description

Description:

This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical injectable products within a regulated sterile manufacturing environment. The position operates and monitors injectable manufacturing equipment and related apparatus to support parenteral product production objectives. It involves the careful handling of raw materials as well as intermediate and finished injectable pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution of injectable manufacturing operations including compounding, filling, and related processes in accordance with established formulations and batch manufacturing records. General maintenance activities on injectable manufacturing equipment and related machinery are performed as required to ensure operational continuity. All activities are executed in strict adherence to Standard Operating Procedures and current Good Manufacturing Practices to meet regulatory requirements. Accurate and timely completion of batch records and manufacturing documentation is maintained as a core accountability. The position participates in process improvement initiatives aimed at enhancing quality, reducing costs, and optimizing production scheduling within the injectable manufacturing function.

Essential Functions:

• Operate and monitor injectable manufacturing equipment and related apparatus in accordance with validated procedures and GMP standards.
• Handle raw materials, intermediate products, and finished injectable goods with care to maintain product quality, sterility, and prevent contamination.
• Perform injectable manufacturing operations including compounding, filling, and related processes per approved batch manufacturing records.
• Mix and compound ingredients for injectable formulations, suspensions, and sterile products per approved procedures.
• Conduct general maintenance on injectable manufacturing equipment and related apparatus to ensure operational readiness.
• Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements.
• Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines.
• Participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.
• Support area cleaning and sanitization activities to maintain a compliant and sterile injectable manufacturing environment.

Additional Responsibilities:

Qualifications

Education:

• B. Pharm / Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge: Licenses:

Required Skills

• Aseptic Manufacturing & Contamination Control
• Data Integrity & Documentation Security
• Documentation & Record Control
• Good Documentation Practices (GDP)
• Manufacturing Process Monitoring
• Material Handling and Storage
• Regulatory Label Compliance Review
• Safety & Hygiene Practices
• Sterility Assurance

Job Info

• Job Identification 8640
• Job Category Manufacturing Process Operations
• Locations Survey No. 168/1/1, Sanand, Gujarat, IN