JOB DETAILS
Manager, Manufacturing Injectables
CompanyAmneal
LocationAhmedabad
Work ModeOn Site
PostedOctober 25, 2026
About The Company
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
About the Role
Description:
Essential Functions:
Additional Responsibilities:
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
- 12 years or more in 12 - 15 Years
Key Skills
cGMP ComplianceAseptic ManufacturingGDPChange ControlDeviation ManagementCAPASOP Lifecycle ManagementProduction PlanningUSFDA Regulatory ComplianceICH GuidelinesEquipment ValidationCalibrationSterilization ProcessesCritical Process ParametersCritical Quality AttributesTeam Training
Categories
ManufacturingHealthcareManagement & LeadershipScience & Research
Job Information
📋Core Responsibilities
The manager is responsible for overseeing end-to-end injectable manufacturing operations while ensuring strict adherence to cGMP, GDP, and aseptic compliance. They also manage equipment validation, deviation investigations, CAPA implementation, and regulatory readiness in alignment with USFDA and ICH standards.
📋Job Type
full time
📊Experience Level
10+
💼Company Size
7735
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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