Senior Manager, Manufacturing Injectables at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

14 Sep, 26

Salary

0.0

Posted On

16 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Aseptic Manufacturing, cGMP Compliance, Vial Line Operations, Isolator Technology, CRABS Technology, Compounding & Reconstitution, CIP & SIP, Environmental Monitoring, Deviation Management, Change Control, Process Validation, Batch Manufacturing Records, Manpower Optimization, Audit Readiness, Sterilization & Depyrogenation, Training & Competency Management

Industry

Pharmaceutical Manufacturing

Description

Description: The role is responsible for end-to-end leadership, supervision, and control of injectable manufacturing operations while ensuring strict adherence to cGMP (current Good Manufacturing Practices). Essential Functions: * Lead and supervise aseptic injectable manufacturing operations on the shopfloor (Vial Line) * Ensure strict compliance with cGMP (current Good Manufacturing Practices) and GMP & Regulatory Compliance (Good Manufacturing Practices and Regulatory Compliance) * Oversee Compounding & Reconstitution and Filling, stoppering and sealing activities * Ensure adherence to Aseptic Techniques and Asceptic Practices and Behaviour * Manage CIP & SIP (Cleaning In Place & Sterilization In Place) and Sterilization & Depyrogenation processes * Oversee Environmental Monitoring and Non-Viable & Viable Particle monitoring * Ensure execution and review of BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) * Drive Change Control & Deviation Management and support Investigation Analysis * Ensure Cross-contamination Prevention and Safety & Hygiene Practices * Support Equipment and Process Validation and Autoclave Operation and Validation * Build team capability through Training and Competency Management Responsible for Manpower Optimization and production optimization * Maintain audit readiness for internal and external regulatory inspections 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.

Responsibilities

Lead and supervise end-to-end aseptic injectable manufacturing operations on the vial line while ensuring strict cGMP compliance. Oversee critical processes including compounding, filling, sterilization, and environmental monitoring to maintain audit readiness.