Senior Executive, Manufacturing Injectables

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Gujarat, India, seeks a Senior Executive to oversee sterile injectable manufacturing in a regulated environment. You will operate and monitor equipment, ensure sterility, and conform to cGMP and FDA/EMA guidelines.

The role emphasizes batch records, process improvement initiatives, and mentoring junior staff, with involvement in compounding, filling, cleaning, and maintenance to ensure product quality and timely production.

Qualifications

• Operates injectable manufacturing equipment following validated procedures and GMP standards.
• Handles raw materials, intermediate products, and finished goods to maintain sterility and prevent contamination.
• Performs and oversees compounding, filling, and related processes per batch manufacturing records.

Responsibilities

• Operate and monitor injectable manufacturing equipment with independence.
• Handle materials to maintain product quality and sterility.
• Perform and oversee manufacturing operations including compounding and filling per records.
• Mix and compound ingredients per procedures for sterile products.
• Conduct general maintenance on equipment to ensure readiness.
• Execute SOPs and maintain accurate batch documentation per cGMP.
• Ensure compliance with FDA and EMA guidelines.
• Lead or participate in process improvement projects to enhance quality and reduce costs.
• Support area cleaning and mentor junior team members in a sterile environment.

Skills

Equipment operation

Sterile manufacturing

Batch documentation

Education

B. Pharm

Master Degree

Job description

JOB DESCRIPTION

This role is responsible for performing a variety of tasks related to the manufacturing of injectable pharmaceutical products within a regulated sterile manufacturing environment at a senior executive level. The position operates and monitors injectable manufacturing equipment and related apparatus to support parenteral product production objectives with greater independence and accountability. 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 and oversight 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 and may lead 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 with greater independence 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 and oversee 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.
• Lead or participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.
• Support area cleaning and sanitization activities and mentor junior team members to maintain a compliant and sterile injectable manufacturing environment.

Education

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

Experience

• 5 years or more in 5 - 8 Years