Manager Manufacturing Injectables

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad is seeking a senior role to oversee end-to-end injectable manufacturing with emphasis on cGMP compliance and GDP across General, Control, and Aseptic areas.

The role requires supervising aseptic operations, ensuring equipment validation, CAPA implementation, and regulatory readiness to align with USFDA/ICH guidelines. Strong documentation and training are essential.

Qualifications

• B. Pharm with extensive experience in injectable manufacturing.
• Preferably M. Pharm with advanced degree in pharma/related field.
• Minimum 12 years of experience in pharma manufacturing, preferably in GMP environments.

Responsibilities

• Ensure strict GMP and GDP activities across General, Control, and Aseptic areas.
• Supervise injectable manufacturing operations during shifts and maintain aseptic compliance.
• Validate and calibrate equipment and lines according to schedules.
• Manage Change Control, Deviations, Investigations, and CAPA with QA.
• Prepare and manage SOPs for sterile manufacturing operations.
• Prepare production plan vs actual reports daily and monthly.

Skills

cGMP compliance

Aseptic manufacturing

CAPA management

Change control

Regulatory readiness

Quality audits

Education

B. Pharm

M. Pharm

Tools

SOP software

Documentation system

Job description

Job Description:

Description:

The role is responsible for ensuring strict cGMP (Current Good Manufacturing Practices) compliance and overseeing end-to-end injectable manufacturing operations for the assigned production line. The role involves supervising aseptic manufacturing activities, ensuring adherence to GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) across General, Control, and Aseptic areas. The position is accountable for equipment and line validation status, change control, deviation management, and CAPA (Corrective and Preventive Action) implementation. The role also leads SOP (Standard Operating Procedure) lifecycle management, production planning versus actual performance monitoring, and regulatory readiness. Additionally, the role requires maintaining accurate online documentation systems and aligning operations with USFDA (United States Food and Drug Administration) and ICH (International Council for Harmonisation) requirements.

Essential Functions:

• Ensure and monitor all GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) activities, including cleaning and sanitization, across General, Control, and Aseptic areas
• Supervise overall injectable manufacturing operations during assigned shifts, ensuring aseptic compliance
• Ensure all equipment and manufacturing lines are validated and calibrated as per approved schedules
• Generate and track general purchase indents for departmental consumables and production items
• Handle Change Control, Deviations, Investigations, and CAPA (Corrective and Preventive Action) in coordination with QA
• Prepare, review, revise, control, and implement SOPs (Standard Operating Procedures) for sterile manufacturing operations
• Prepare production plan vs actual reports on daily and monthly basis based on material availability
• Ensure strict adherence to aseptic techniques and sterilization processes during injectable manufacturing
• Monitor CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) during batch execution
• Support internal and external audits and ensure compliance with USFDA and ICH guidelines
• Responsible for preparation & review of the all-master documents of production
• Responsible to update on self-hygiene
• Responsible to attend the training as per training schedule and to ensure training of the team as per TNI

Additional Responsibilities:

• Responsible to give training to all the subordinates, technicians, and operators of the department.
• Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
• Responsible to attend the training as per training schedule and to ensure training as per TNI.

Qualifications

Education:

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 12 years or more in 12 - 15 Years

Specialized Knowledge:

Licenses:

Requirements: