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

Skills

Compounding, Sterile Filtration, Autoclave Operations, cGMP, USFDA, EU GMP, ALCOA+, Data Integrity, Aseptic Practices, Solution Stability, Mixing Dynamics, Biologics Preparation, Peptide Formulation, Batch Reconciliation, Equipment Cleaning, Training

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities:- Execute weighing, dispensing, solution preparation, pH adjustment, mixing, and other compounding activities as per BMR.- Supervise preparation of bulk solution for sterile injectables, including biologics and peptide formulations.- Ensure accurate calculation of quantities, yields, and batch reconciliation.- Perform sterile filtration and ensure filtration steps follow validated parameters.- Operate and monitor mixing vessels, jacketed tanks, sterile filtration systems, transfer pumps, and autoclaves.- Ensure equipment cleaning, sanitization, and setup as per SOPs.- Maintain documentation including BMR, logbooks, equipment usage records, and filtration records.- Follow ALCOA and ALCOA+ principles for data integrity.- Ensure adherence to cGMP, USFDA, EU GMP, and Annex 1 guidelines.- Coordinate with QA, Engineering, and Warehouse for timely production.- Train operators and helpers involved in compounding and filtration. Technical / Functional Skills:- Understanding of cGMP, USFDA, EU GMP.- Knowledge of ALCOA & ALCOA+ data integrity principles.- Hands-on experience in compounding, sterile filtration, and autoclave operations.- Knowledge of aseptic practices, solution stability, and mixing dynamics.- Familiarity with biologic or peptide solution preparation. Behavioral Competencies:- Positive attitude and strong willingness to learn.- Ethical conduct and honesty in operations.- People management and coordination skills.- Attention to detail and compliance mindset.- Good communication and teamwork abilities. Injectables–Specific Expectations:- Experience in injectable compounding is mandatory.- Exposure to biologic or peptide product preparation preferred.- Knowledge of sterilization principles, filter integrity checks, and aseptic solution transfers

Responsibilities

The officer will execute weighing, dispensing, solution preparation, pH adjustment, mixing, and other compounding activities according to the Batch Manufacturing Record (BMR), while supervising the preparation of bulk solutions for sterile injectables, including biologics and peptides. Key duties involve ensuring accurate calculations, performing sterile filtration following validated parameters, operating specialized equipment, and maintaining comprehensive documentation.