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.
Preferred candidate profile 15 to 20 years in pharma, with 5+ years leading maintenance in a USFDA-Approved API facility.
📌 Sr Manager Maintenance Pharma Api Usfda Plant Tarapur
🏢 IPCA
📍 Tarapur