Senior 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

Weighing, Dispensing, Solution Preparation, Sterile Filtration, CIP/SIP, Aseptic Transfers, Yield Calculations, cGMP, Annex 1, Data Integrity, Coaching, Problem-Solving, Batch Scale-ups, Tech Transfers, Compounding Systems, Integrity Testing

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities:- Supervise weighing, dispensing, solution preparation, pH/osmolality adjustment, and mixing as per BMR- Plan and execute sterile filtration with pre- and post- integrity testing; maintain filter traceability- Oversee CIP/SIP of compounding vessels, hold tanks, and transfer lines; verify readiness for use- Manage aseptic transfers to filling area; ensure closed transfers/single-use systems where applicable- Perform yield calculations, reconciliation, and ensure adherence to material and yield tolerances- Monitor critical parameters (temperature, mixing speed, time) and document IPC results- Coordinate with QA/Engineering/Warehouse to secure timely materials and equipment availability- Review BMR/logbooks, ensure ALCOA-compliant entries; support deviations, CAPA, and change controls- Train/mentor operators on solution prep, filtration, and safe handling of potent/biologic materials- Drive improvements in right-first-time batches, hold-time compliance, and line changeover time Technical / Functional Skills:- Hands-on with compounding systems, jacketed tanks, magnetic mixers, and transfer pumps- Expertise in CIP/SIP, steam quality basics, condensate management, and sterile connections- Filter selection (PES/PVDF), sizing, wetting agents, and integrity test methods (bubble point, diffusion)- Understanding of solution stability (temperature/shear/light), and mixing dynamics- Experience with biologic/peptide compounding (cold chain handling, shear sensitivity)- Strong grasp of cGMP, Annex 1, US FDA expectations, and data integrity (ALCOA+) Behavioral Competencies:- Ownership, discipline, and a strong compliance mindset- Ethical behavior, honesty, and accuracy in documentation- Clear communication and cross-functional coordination- Ability to coach operators/technicians and manage shifts- Structured problem-solving and calm decision-making on the floor Injectables–Specific Expectations:- Proven experience in injectable compounding and sterile filtration- Knowledge of aseptic transfers and contamination control in compounding rooms- Ability to manage batch scale-ups and tech transfers with PQ support

Responsibilities

The Senior Officer will supervise critical manufacturing steps including weighing, dispensing, solution preparation, and sterile filtration, while ensuring adherence to BMRs and maintaining traceability of materials and equipment. This role also involves overseeing cleaning/sterilization processes, managing aseptic transfers, performing yield reconciliation, and documenting all critical parameters and IPC results.