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Deputy General Manager, Quality Management Systems 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

No

Skills

QMS Team Development, Document Governance, Change Control, QMS Review Meetings, Audit Readiness, CAPA Effectiveness, Deviation Reduction, eQMS Improvements, cGMP, Annex 1, ICH Q9/Q10, Data Integrity, TrackWise, MasterControl, Risk-Based Decision Making, Cross-functional Influence

Industry

Pharmaceutical Manufacturing

Description
Key Responsibilities:-  Form, mentor, and develop the Manufacturing QMS team (Executives/Senior Executives)- Establish document governance for SOPs/WIs/BMRs and ensure timely revisions and harmonization- Lead Manufacturing Change Control governance and alignment with QA/CCB- Chair weekly QMS review meetings and publish site-wide QMS dashboards- Ensure audit/inspection readiness; lead responses to regulatory/customer observations- Drive CAPA effectiveness, deviation reduction initiatives, and trend reviews- Champion eQMS improvements, digitization projects, and training effectiveness programs  Technical / Functional Skills:- Deep knowledge of cGMP, Annex 1, ICH Q9/Q10, and data integrity (ALCOA+)- Hands-on experience with enterprise eQMS platforms (TrackWise, MasterControl, or equivalent)- Experience managing change controls, deviations, investigations, and CAPA at scale- Strong understanding of documentation lifecycle management and regulatory expectations  Behavioral Competencies:- Strategic leadership with strong cross-functional influence- Mentoring, coaching, and capability-building mindset- Decision-making based on risk-based and data-driven principles
Responsibilities
The role involves leading and governing the Manufacturing Quality Management Systems (QMS) program, which includes forming and mentoring the QMS team, establishing document governance for SOPs/WIs/BMRs, and leading Change Control governance.