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Executive, 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

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Isolator, RABS, Qualification, Validation, Media Fills, VHP Cycles, Glove Integrity Testing, Contamination Control Strategy, SCADA, BMS, HMI, Leadership, Stakeholder Management, Cartridge Filling, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities:- Lead day-to-day operations on isolator-based cartridge filling lines- Ensure readiness of filling lines, line clearance, and coordination with QA/Engineering- Drive qualification & validation activities: equipment qualification, media fills, process simulations- Review batch documents, deviation investigations, CAPA, and change controls- Ensure in-process controls: fill volume, crimp integrity, torque, visual checks- Lead investigation teams for any filling-related process failures Technical / Functional Skills:- Strong understanding of isolator/RABS-based filling systems- Expertise in qualification activities: URS, DQ, IQ, OQ, PQ- Hands-on knowledge of media fills, VHP cycles, and glove integrity testing- Understanding of CCS (Contamination Control Strategy) requirements- Able to interpret SCADA/BMS/HMI data for troubleshooting Behavioral Competencies:- Strong leadership and decision-making abilities- Excellent communication and stakeholder management- High compliance and documentation discipline Injectables–Specific Expectations:- Experience handling cartridge filling lines in isolator environment- Understanding of regulatory expectations (USFDA, EMA, WHO)- Ability to lead validation and requalification cycles

Responsibilities

The Executive will lead the daily operations of isolator-based cartridge filling lines, ensuring line readiness, clearance, and coordination with Quality Assurance and Engineering departments. Key duties include driving qualification and validation activities, reviewing batch documentation, and leading investigations for process failures.