Executive Engineer QMS

Role Summary:

As part of the Engineering team, the Executive Engineer QMS will oversee quality systems integration within utilities, facility infrastructure, and operational processes. This role focuses on rigorous documentation, CAPA implementation, change control, and incident/deviation managementensuring compliance with pharmaceutical standards in water systems, HVAC, and other critical utilities. Candidates with backgrounds in injectables, oral solid dosage (OSD), or biosimilars are strongly encouraged.

Key Responsibilities:

• Documentation & Compliance:
• Control SOPs, qualification protocols, engineering records.
• Ensure alignment of engineering documentation with regulatory norms.
• Utility System Oversight:
• Maintain and monitor water systems (PW/WFI), HVAC, compressed air, and other utilities.
• Ensure systems meet pharma-grade specifications and cGMP compliance.
• CAPA & Deviation Management:
• Lead investigations on engineering-related deviations and incidents.
• Collaborate with cross-functional teams to resolve issues and define CAPAs.
• Change Control & Incident Reporting:
• Manage and document change requests for engineering infrastructure.
• Track incidents and ensure timely reporting and closure.
• Audit Support:
• Represent engineering in quality audits and inspections.
• Maintain QMS compliance across engineering processes and systems.

Qualifications:

• B.E./B.Tech or M.Tech in Mechanical, Electrical, or Chemical Engineering.
• 45 years’ experience in pharmaceutical engineering/QMS domains.
• Hands-on knowledge of injectable, OSD, or biosimilar facility operations.
• Familiarity with regulatory frameworks.