Senior Executive, Filling & Sealing

Amneal Pharmaceuticals LLC; Ahmedabad District; Presencial; INR 400 000 - 600 000; Tempo integral

Resumo da oferta

Amneal Pharmaceuticals LLC in Gujarat, India, seeks a dedicated operator for a regulated sterile manufacturing environment. You will handle raw materials and finished products to maintain sterility and quality.

The role involves operating filling and sealing equipment for injectable and sterile dosage forms, performing maintenance, documenting batch records, and supporting process improvements within GMP/cGMP guidelines.

Qualificações

• B. Pharm degree is required.
• Master degree (MS/MA) is preferred.

Responsabilidades

• Operate and monitor filling and sealing equipment in GMP environment.
• Handle raw materials, intermediates and finished sterile goods with care to maintain quality and sterility.
• Perform filling and sealing operations for injectable and sterile dosage forms per approved batch records.
• Conduct general maintenance on filling machines and related equipment.
• Maintain accurate batch documentation in accordance with cGMP requirements.
• Support process improvement projects to enhance quality, reduce costs, and optimize scheduling.

Conhecimentos

GMP compliance

Sterile manufacturing

Formação académica

B. Pharm

Master Degree (MS/MA)

Ferramentas

Filling machines

Sealing equipment

Descrição da oferta de emprego

JOB DESCRIPTION

This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical ingredients and finished products within a regulated sterile manufacturing environment. The position operates and monitors filling and sealing equipment and related manufacturing apparatus to support parenteral and sterile product production objectives. It involves the careful handling of raw materials as well as intermediate and finished pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution of filling and sealing operations for injectable and sterile dosage forms in accordance with established formulations and batch manufacturing records. General maintenance activities on filling machines, sealing 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 filling and sealing function.

Description

JOB DESCRIPTION

This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical ingredients and finished products within a regulated sterile manufacturing environment. The position operates and monitors filling and sealing equipment and related manufacturing apparatus to support parenteral and sterile product production objectives. It involves the careful handling of raw materials as well as intermediate and finished pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution of filling and sealing operations for injectable and sterile dosage forms in accordance with established formulations and batch manufacturing records. General maintenance activities on filling machines, sealing 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 filling and sealing function.

Essential Functions

• Operate and monitor filling and sealing equipment and related manufacturing apparatus in accordance with validated procedures and GMP standards.
• Handle raw materials, intermediate products, and finished sterile goods with care to maintain product quality, sterility, and prevent contamination.
• Perform filling and sealing operations for injectable and sterile dosage forms per approved batch manufacturing records.
• Mix and compound ingredients for liquid products, suspensions, and sterile formulations per approved procedures as required.
• Conduct general maintenance on filling machines, sealing 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 manufacturing environment.

QUALIFICATIONS

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

Experience

• 2 years or more in 2 - 5 Years