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Officer, Manufacturing Injectables at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

25 Jun, 26

Salary

0.0

Posted On

27 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Cgmp, Sops, Aseptic Behavior, Gowning Procedures, Cleanroom Discipline, Filling Machines, Filtration Systems, Autoclaves, Bmrs, Deviation Handling, Capa, Risk Assessments, Alcoa, Sterilization, Filtration Integrity, Injectable Fill-Finish

Industry

Pharmaceutical Manufacturing

Description
Key Responsibilities:-  Supervise operations in the filling and filtration sections as per cGMP and SOPs.- Ensure adherence to aseptic behavior, gowning procedures, and cleanroom discipline.- Operate and monitor filling machines, filtration systems, and autoclaves.- Review and ensure correctness of BMRs, logbooks, and documentation.- Support activities including line clearance, equipment preparation, and area readiness.- Collaborate with QA, Engineering, and Support Functions.- Ensure compliance with US FDA, EU GMP, and Annex 1.- Support deviation handling, CAPA, and risk assessments.- Train operators on cGMP, ALCOA, and safe practices.- Maintain oversight of safety, hygiene, and environmental guidelines.  Technical / Functional Skills:- Understanding of cGMP, US FDA, EU GMP.- Knowledge of ALCOA & ALCOA+ principles.- Experience with injectable filling, sterile filtration, autoclave operations.- Knowledge of aseptic practices and documentation.  Behavioral Competencies:- Positive attitude and proactive approach.- Ethical behavior and honesty.- Strong people management.- Good communication and coordination.  Injectables–Specific Expectations:- Injectable fill-finish experience mandatory.- Exposure to biologic or peptide product filling preferred.- Understanding of sterilization, filtration integrity, and aseptic interventions
Responsibilities
The Officer will supervise operations within the filling and filtration sections, ensuring strict adherence to cGMP and SOPs, including operating machinery and monitoring documentation correctness. This role also involves supporting various readiness activities and collaborating with Quality Assurance and Engineering departments.