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Senior 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

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

QMS, SOP Development, Aseptic Processing, Cartridge Manufacturing, PFS Manufacturing, Isolator Operations, Change Control, Risk Assessment, Deviation Investigation, CAPA, GMP Compliance, Annex 1 Compliance, Auditing, Regulatory Inspections, Cross-functional Collaboration, Sterile Operations

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities - Lead development and implementation of SOPs for aseptic, cartridge / PFS, and isolator filling operations. - Act as Operations owner for project-phase change controls and risk assessments. - Lead deviation investigations during commissioning, qualification, and readiness activities. - Drive CAPA effectiveness and sustainability from Operations perspective. - Support audits, mock inspections, and regulatory inspections. - Strong cross-functional collaboration with QA, QC, Engineering, Validation, and Automation teams.

Responsibilities

Lead the development and implementation of SOPs for aseptic, cartridge, and isolator-based filling operations. Manage project-phase change controls, risk assessments, and lead deviation investigations to ensure GMP and Annex 1 compliance.