We are looking for IT GMP qualified to lead GMP operations, ensure regulatory compliance, and support critical manufacturing systems at our Kharakadi, Vadodara facility.
Role Summary
Lead IT GMP Operations across multiple manufacturing sites, ensuring GMP application compliance, regulatory readiness, data integrity, and effective stakeholder collaboration while managing a high-performing team.
Key Responsibilities :-
Lead IT GMP Operations for QC and Manufacturing systems across multiple sites.
Manage GMP applications and ensure regulatory compliance.
Support USFDA and other regulatory audits and inspections.
Oversee Manufacturing Systems such as SCADA, IPC, Empower, Chromeleon.
Ensure Data Integrity, CSV, and Infrastructure Qualification compliance.
Drive compliance with 21 CFR Part 11, Annex 11, GAMP 5, & PIC/S guidelines.
Manage Active Directory,
Server Administration, and Security Policies.
Lead automation initiatives and continuous improvement projects.
Collaborate with cross-functional stakeholders to support business operations.
Lead and develop a team supporting multiple manufacturing sites.
Required Qualifications :-
10+ years of experience in IT GMP Operations.
Robust expertise in GMP Applications & Manufacturing Systems.
Experience with SCADA, IPC, Empower, Chromeleon & CSV.
Exposure to regulatory audits and compliance requirements.
Proven team leadership and stakeholder management experience.
Robust analytical, problem-solving and communication skills.