Sr. Manager - Maintenance (Pharma API USFDA Plant)

Ipca; Munger; Presencial; INR 4.000.000 - 6.000.000; Jornada completa

Descripción de la vacante

Ipca in India seeks a seasoned maintenance leader for API operations. You will head preventive and breakdown maintenance of reactors, centrifuges, and purification equipment, ensure regulatory readiness for USFDA audits, and drive QMS processes, deviations, CAPAs, and change controls.

Strong EHS discipline and LOTO safety are required, with 15–20 years pharma experience and 5+ years in USFDA‑approved API facilities.

Formación

• 15 to 20 years in pharma industry.
• 5+ years leading maintenance in USFDA-approved API facilities.
• Experience with QA/QMS processes and regulatory audits.

Responsabilidades

• Plant maintenance: preventive and breakdown maintenance of API equipment (Reactors, Centrifuges, ANFDs, RCVDs).
• Utility operations: oversee HVAC, PW systems, Chillers and Boilers.
• Lead regulatory audits facing USFDA and EDQM.
• Draft and manage engineering Change Controls, Deviations, CAPAs, audit trails.
• Oversee qualification lifecycle (DQ/IQ/OQ/PQ) and enforce EHS/LOTO safety.

Conocimientos

Maintenance leadership

Regulatory compliance

CAPA management

Audit readiness

Descripción del empleo

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.