Line Manager DM Mgr Manufacturing Injectables

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad seeks an experienced professional to supervise aseptic manufacturing, ensuring GMP, GDP and regulatory readiness. You will oversee equipment validation, change control, deviation management and CAPA implementation, while maintaining accurate online documentation.

Responsibilities include SOP lifecycle management, production planning vs actual, and adherence to USFDA and ICH guidelines.

Qualifications

• GMP/GDP and aseptic manufacturing knowledge required.
• Experience with sterile injectable operations and equipment validation.
• Strong documentation discipline and CAPA handling.

Responsibilities

• Supervise aseptic injectable manufacturing operations across shifts.
• Ensure equipment and lines are validated and calibrated per schedules.
• Lead change control, deviations, investigations and CAPA activities with QA.
• Prepare, review, and implement SOPs for sterile manufacturing.
• Monitor production plan vs actual against material availability.
• Support audits and regulatory readiness with USFDA/ICH guidance.

Skills

GMP compliance

GDP

Aseptic manufacturing

Validation

Education

B. Pharm

M. Pharm

Job description

Job Description:

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

Requirements: