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Executive, QMS at Amneal India

Sanand, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

02 Aug, 26

Salary

0.0

Posted On

04 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QMS, SOP Preparation, Document Control, Change Control, Deviation Investigation, CAPA Implementation, Injectable Operations, Sterile Operations, Cartridge Manufacturing, PFS Manufacturing, Isolator-based Filling, Aseptic Filling, Quality Assurance, Validation, Engineering, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities - Preparation and implementation of SOPs, STPs, formats, and records for injectable operations including cartridge / PFS and isolator-based filling lines. - Execution of document control activities including issuance, revision, and archival. - Initiation and tracking of change controls related to facility, equipment, utilities, and documentation. - Support deviation documentation and investigations during commissioning and qualification phases. - Support CAPA implementation and tracking. - Cross-functional coordination with QA, QC, Engineering, Validation, and Projects teams.

Responsibilities

The role involves managing Quality Management System activities including SOP preparation, document control, and change management for injectable operations. It also requires supporting deviation investigations and CAPA implementation while coordinating across engineering and quality teams.