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General Manager / Sr. General Manager, Regulatory Affairs | Nce

Amneal
Amneal
0-2+ years
Not Disclosed
Ahmedabad, India
10 March 19, 2026
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Officer, Manufacturing Injectables

Company: Not Specified
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Experience: Typically 0–2+ Years (Manufacturing / Pharma Operations)
Qualification: B.Pharm / B.Sc or Any Graduation
Salary Range: Not Specified

Job Overview

The company is hiring an Officer, Manufacturing Injectables responsible for handling and monitoring product processing activities at vendor sites, ensuring compliance with SOPs and maintaining cold chain integrity during gamma irradiation processes.

The role involves managing material handling, temperature control, data logging, and ensuring quality and safety of products throughout the irradiation and transportation process.

Key Responsibilities

Product Handling & Cold Chain Management

Ensure proper handling of products at vendor site.
Manage removal of gel packs and transfer of materials to cold chain vehicles.
Ensure correct placement of gel packs post gamma process as per SOP.

Gamma Irradiation Process

Ensure availability of sufficient dry ice prior to gamma process.
Verify dry ice weight in outer boxes as per SOP requirements.
Ensure gamma irradiation is conducted strictly as per approved procedures.

Temperature Monitoring & Data Logging

Place and operate data loggers during the process.
Ensure required temperature is achieved and maintained.
Record data logger details in standard formats.

Quality & Compliance

Ensure no damage to products or containers during processing.
Monitor all vendor site activities in compliance with SOPs.
Ensure adherence to quality and safety standards.

Post-Processing & Dispatch

Ensure proper palletization as per SOP after gamma process.
Verify and record temperature of cold chain vehicle before dispatch.
Ensure proper loading of products into transport vehicles.

Documentation & Records

Verify correctness and completeness of vendor batch records.
Maintain accurate documentation as per standard procedures.

Required Skills

Manufacturing & Operations

Understanding of pharmaceutical manufacturing processes.
Knowledge of cold chain handling and product safety.

Quality & Compliance

Familiarity with SOPs and regulatory compliance.
Attention to detail in monitoring and documentation.

Technical Skills

Basic knowledge of data loggers and temperature monitoring.
Ability to handle operational equipment and processes.

Analytical & Problem Solving

Ability to identify issues and ensure corrective actions.
Strong observation and monitoring skills.

Communication

Basic coordination and reporting skills.
Ability to work with vendor teams and internal stakeholders.

Basic Qualifications

B.Pharm / B.Sc or Any Graduation

Preferred Competencies

Knowledge of injectables manufacturing
Experience in cold chain and gamma irradiation processes
Understanding of batch records and documentation

Key Competencies

Manufacturing operations and product handling
Cold chain and temperature control
Quality compliance and SOP adherence
Data logging and process monitoring
Documentation and record management

About the Company

Not Specified