Actively Hiring
IP
Sr. Manager - Maintenance (Pharma API USFDA Plant)
Ipca
Tarapur
Skills:
Plant Maintenance
Job Description
Job Title: Sr. Manager - Maintenance (Pharma API USFDA Plant)
Company: Ipca
SAP Module: SAP PM
Roles & Responsibilities:
Role & responsibilities
* Plant Maintenance: Manage preventive and breakdown maintenance of API equipment (Reactors, Centrifuges, ANFDs, RCVDs).
* Utility Operations: Oversee critical utilities, including HVAC (Cleanrooms), Purified Water (PW) systems, Chillers, and Boilers.
* Regulatory Compliance: Act as the primary engineering lead to face and defend USFDA and EDQM regulatory audits.
* Engineering QMS: Draft and manage engineering Change Controls, Deviations, CAPAs, and audit trails.
* Validation & Safety: Oversee the equipment qualification lifecycle (DQ/IQ/OQ/PQ) and enforce strict EHS / LOTO safety standards.
15 to 20 years in pharma, with 5+ years leading maintenance in a USFDA-Approved API facility.
Work Location: Tarapur, India
Availability: Full time
Requirements
Preferred candidate profile
Key Skills: Plant Maintenance
Salary: Not disclosed
