Line Manager (DM/ Mgr), Manufacturing Injectables
Amneal Pharmaceuticals · Ahmedabad
- Experience12–13 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelexecutive
- Posted16 Sept 2026
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is hiring in Ahmedabad in pharma biotech. This role looks for around 12+ years of experience.
Skills
- GMP
- GDP
- aseptic manufacturing
- equipment validation
- line validation
- calibration
- change control
- deviation management
- CAPA
- SOP management
- production planning
- aseptic techniques
- sterilization processes
- Critical Process Parameters
- Critical Quality Attributes
- USFDA requirements
- ICH guidelines
- B. Pharm
The role
A manufacturing operations manager at a pharmaceutical company supervises aseptic injectable manufacturing, ensuring GMP compliance and managing CAPA. The role also oversees sterile manufacturing SOPs and USFDA requirements.
Full job description
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 areasSupervise overall injectable manufacturing operations during assigned shifts, ensuring aseptic complianceEnsure all equipment and manufacturing lines are validated and calibrated as per approved schedulesGenerate and track general purchase indents for departmental consumables and production itemsHandle Change Control, Deviations, Investigations, and CAPA (Corrective and Preventive Action) in coordination with QAPrepare, review, revise, control, and implement SOPs (Standard Operating Procedures) for sterile manufacturing operationsPrepare production plan vs actual reports on daily and monthly basis based on material availabilityEnsure strict adherence to aseptic techniques and sterilization processes during injectable manufacturingMonitor CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) during batch executionSupport internal and external audits and ensure compliance with USFDA and ICH guidelinesResponsible for preparation & review of the all-master documents of productionResponsible to update on self-hygieneResponsible 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