Junior Officer, Manufacturing Process Operations

Amneal Pharmaceuticals LLC

India

On-site

INR 350,000 - 550,000

Full time

10 days ago

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Job summary

Amneal Pharmaceuticals LLC in Visakhapatnam, Andhra Pradesh, India, seeks a Junior Officer, Manufacturing Process Operations to support API production by performing process activities, handling materials, and documenting operations in a regulated environment.

You will operate reactors, centrifuges, dryers, and filtration systems, ensure cGMP compliance, and contribute to continuous improvement and batch traceability.

Qualifications

  • Bachelor's degree in science required; master's preferred.
  • Minimum 1 year of experience in API manufacturing or related operations.
  • Experience with GMP, GDP, and batch documentation practices.

Responsibilities

  • Execute API manufacturing activities (charging, reactions, filtration, drying, material transfers) per batch records.
  • Maintain compliance with regulatory requirements including FDA/EMA guidelines.
  • Operate reactors, centrifuges, dryers, and filtration systems per SOPs.
  • Handle raw materials and intermediates following GMP and safety rules.
  • Record process parameters, observations, and activities in batch documentation.
  • Perform line clearance, cleaning, and basic maintenance per procedures.
  • Identify deviations and safety concerns; support in-process checks and sampling.
  • Contribute to process improvement, yield optimization, and operational efficiency.

Skills

Data Integrity
Documentation
GDP
In-Process Checks
Manufacturing Process Documentation
Material Handling
Process Monitoring
Process Optimization
Regulatory Compliance
Safety Practices

Education

Bachelor's Degree (BA/BS) in Science
Master's Degree (MS/MA) Preferred

Job description

Junior Officer, Manufacturing Process Operations

Visakhapatnam, Andhra Pradesh, India

Job Description

Description: This role supports execution of API manufacturing operations by performing process activities and ensuring accurate documentation in a regulated production environment. The role involves operating process equipment and executing batch manufacturing steps such as charging, reaction monitoring, filtration, drying, and material transfers in accordance with batch manufacturing records and standard operating procedures. The incumbent handles raw materials and intermediates while ensuring adherence to GMP, safety, and quality standards. It maintains accurate and timely documentation of all manufacturing activities to ensure traceability and audit readiness. The role contributes to consistent batch execution, regulatory compliance, and operational efficiency while supporting continuous improvement initiatives in API manufacturing processes.

Essential Functions
  • Execute API manufacturing activities (charging, reactions, filtration, drying, material transfers) as per batch manufacturing records
  • Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines
  • Operate process equipment such as reactors, centrifuges, dryers, and filtration systems in compliance with SOPs
  • Handle raw materials, solvents, and intermediates in line with GMP and safety requirements
  • Record process parameters, observations, and activities accurately in batch documentation
  • Ensure adherence to cGMP, safety guidelines, and regulatory requirements during all operations
  • Perform equipment cleaning, line clearance, and basic maintenance as per defined procedures
  • Maintain cleanliness, housekeeping, and safe working conditions in manufacturing areas
  • Identify and report process deviations, abnormalities, and safety concerns promptly
  • Support in-process checks and sampling to ensure product quality and consistency
  • Participate in process improvement, yield enhancement, and operational efficiency initiatives
Education
  • Bachelors Degree (BA/BS) B. Sc. - Required
  • Master Degree (MS/MA) M. Sc. - Preferred
Experience
  • 1 year or more in 1 - 4 Years
Required Skills
  • Data Integrity & Documentation Security
  • Documentation & Record Control
  • Good Documentation Practices (GDP)
  • In-Process Checks
  • Manufacturing Process Documentation
  • Material Handling and Storage
  • Process Monitoring & Control
  • Process Optimization
  • Regulatory Compliance
  • Safety & Hygiene Practices
Job Info
  • Job Identification 8761
  • Job Category Manufacturing Process Operations
  • Posting Date 08/17/2026, 05:22 AM
  • Locations Plot No: 68, JNPC, Visakhapatnam, AP, 531019, IN
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