Senior Executive Filling And Sealing

Amneal Pharmaceuticals LLC; Ahmedabad District; Sur place; INR 450 000 - 650 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC in India seeks a qualified operator for sterile manufacturing, handling filling and sealing of parenteral products within a GMP environment. The role emphasizes maintaining sterility and batch integrity while following approved procedures.

The candidate should have a B. Pharm (required) and a master’s degree preferred, with 2+ years in sterile production. On-site work with focus on quality and compliance.

Qualifications

• 2+ years in sterile pharmaceutical manufacturing.
• Experience with batch records and cGMP.

Responsabilités

• Operate and monitor filling and sealing equipment per validated GMP procedures.
• Handle raw materials, intermediates, and finished sterile products to prevent contamination.
• Perform filling and sealing for injectable and sterile dosage forms per batch records.
• Mix and compound ingredients for liquids and sterile formulations per procedures.
• Conduct general maintenance on filling machinery and sealing equipment.
• Maintain accurate batch documentation in compliance with cGMP.
• Ensure compliance with FDA and EMA guidelines.
• Participate in process improvement to enhance quality and efficiency.
• Support area cleaning and sanitization to maintain sterile environment.

Connaissances

GMP compliance

Documentation accuracy

Attention to detail

Quality mindset

Team collaboration

Formation

B. Pharm

Master Degree (MS/MA) M. Sc.

Outils

Filling machines

Sealing equipment

Description du poste

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.

Education

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

Experience

• 2 years or more in 2 - 5 Years