Line Manager (DM/ Mgr), Manufacturing Injectables

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Amneal Pharmaceuticals seeks an experienced head of aseptic manufacturing in Ahmedabad to supervise GMP and GDP across General, Control and Aseptic areas. The role emphasizes equipment validation, change control, deviations, CAPA, and SOP lifecycle management within sterile injectable production.

You will monitor production planning vs actual performance, ensure strict aseptic techniques, and align operations with USFDA and ICH requirements.

Qualifications

• Experience in GMP and GDP across General, Control, and Aseptic areas.
• Lead equipment and line validation and calibration per schedule.
• Manage Change Control, Deviations, Investigations and CAPA with QA.
• Prepare and manage SOP lifecycle for sterile manufacturing operations.
• Produce production plan vs actual reports daily and monthly.
• Ensure aseptic techniques and sterilization for injectable manufacturing.
• Support audits and compliance with USFDA and ICH guidelines.
• Maintain master production documents and training per schedule.

Responsibilities

• Monitor GMP and GDP activities across General, Control and Aseptic areas.
• Supervise injectable manufacturing operations during shifts, ensuring aseptic compliance.
• Ensure all equipment and lines are validated and calibrated as per schedules.
• Prepare production plan vs actual reports on daily and monthly basis.
• Handle deviations, investigations and CAPA in coordination with QA.
• Prepare, review and implement SOPs for sterile manufacturing.
• Support internal and external audits and regulatory readiness.

Skills

GMP knowledge

Aseptic techniques

Change control

Documentation

Education

B. Pharm

M. Pharm

Job description

JOB DESCRIPTION

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 - Required / M. Pharm - Preferred

Experience: minimum Experience 12 Years in injectable plant