Assistant, Manufacturing Injectables at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

30 Jun, 26

Salary

0.0

Posted On

01 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Equipment Design, Utilities, Interlocks, Control Logic, Troubleshooting, Attention to Detail, Teamwork, Communication, Ownership Mindset, Parameter Verification, Aseptic Gowning, Cleanroom Behaviors, GMP Compliance, Documentation, Production Monitoring, Cycle Tuning

Industry

Pharmaceutical Manufacturing

Description

A) DESIGN REVIEW & FAT * Understand basket/loading layouts, spray arm motion, and filter housings. * Observe FAT demos of wash steps, detergents dosing, and HMI sequences. * Review utilities (DI/WFI, compressed air) and basic interlocks. * Verify nozzle layout, pump curves, filtration stages, and utilities. * Review interlocks/alarms; confirm safety and emergency stop logic. * Assess drainage paths and potential dead legs. B) SAT / IQ / OQ / PQ * Support IQ/OQ: execute repeated wash cycles, sampling, and visual checks. * Document cycle parameters and assist in reproducibility verification. * Support PQ by preparing standardized loads and recording results. * Lead OQ: pressure/flow checks, sensor calibration, and cycle tuning. * Troubleshoot blocked nozzles, cavitation, and chemical dosing variability. * Support PQ reproducibility and finalize validated parameters. C) ROUTINE PRODUCTION * Load parts as per pattern; verify chemical dosing and spray arm rotation. * Operate cycles; monitor pressures/temperatures; handle alarms. * Clean machine surfaces and maintain GDP-compliant records. * Perform PM on pumps, seals, filters; manage spares and change parts. * Trend wash performance; reduce rewash rates and downtime. * Coordinate with QA/Validation for periodic verification. D) GMP, EHS & COMPLIANCE * Adhere to cGMP, GDP, and site SOPs; ensure data integrity at all times. * Follow aseptic gowning and cleanroom behaviors for Grade A/B/C as applicable. * Comply with EHS guidelines; report near-misses/unsafe conditions promptly. * Maintain housekeeping (5S) and status labeling of equipment and areas. F) DOCUMENTATION * Complete BMR/BPR entries, equipment logbooks, cleaning and line clearance records. * Support deviation/CAPA, change control, and risk assessments as applicable. * Maintain qualification/validation records during SAT, IQ, OQ, PQ. 1. SKILLS & COMPETENCIES * Technical: Understanding of equipment design, utilities, interlocks, and control logic. * Operational: Setup, start-up/shutdown, parameter verification, basic troubleshooting. * Behavioral: Attention to detail, teamwork, communication, ownership mindset. 2. EDUCATION & EXPERIENCE * ITI/Diploma (Mech/Elect/Instr) / B.sc or B.Tech preferred. * 3 to 7 years of experience in sterile injectable manufacturing with hands-on equipment operation, FAT/SAT participation, troubleshooting, and qualification exposure (IQ/OQ/PQ). 3. PHYSICAL & ENVIRONMENTAL REQUIREMENTS * Ability to work in classified cleanrooms; prolonged standing; occasional lifting up to ~20–25 kg. * Willingness to work in rotational shifts and extended hours during validation.

Responsibilities

The Assistant, Manufacturing Injectables will be involved in design review, factory acceptance testing (FAT), and routine production operations. They will also ensure compliance with GMP and maintain documentation throughout the qualification processes.