Plant Head - Sterile Injectables

Getwell Pharmaceuticals; Rewari; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Getwell Pharmaceuticals seeks an experienced Manufacturing Leader to oversee end-to-end plant operations across Production, Engineering, Warehouse, Utilities, Maintenance, EHS and Compliance, driving productivity, cost optimization and lean manufacturing to support global markets from Haryana, India.

You will ensure cGMP compliance with USFDA, EMA, MHRA, PIC/S and WHO; lead regulatory inspections and audits; provide technical oversight for aseptic processing, validation and technology transfer;

Responsibilities

• Lead end-to-end plant operations including Production, Engineering, Warehouse, Utilities, Maintenance, EHS and Compliance functions.
• Drive operational excellence through productivity improvement, cost optimization, capacity enhancement and lean manufacturing initiatives.
• Ensure uninterrupted manufacturing operations with high equipment uptime, robust maintenance systems and effective resource utilization.
• Establish manufacturing strategies aligned with business growth and regulatory expectations for global markets.
• Ensure sustained compliance with current cGMP requirements of USFDA, EMA, MHRA, PIC/S and WHO.
• Lead and manage regulatory inspections, customer audits and corporate audits with strong compliance outcomes.
• Drive implementation of Contamination Control Strategy (CCS), Quality Risk Management (QRM), Data Integrity and Quality Culture initiatives.
• Ensure effective investigation systems for deviations, OOS/OOT, CAPA, change control and risk assessments.
• Provide technical leadership for aseptic processing, lyophilization, terminal sterilization and visual inspection operations.
• Support technology transfer, process validation, cleaning validation, media fills and continued process verification activities.
• Oversee qualification and lifecycle management of equipment, utilities and computerized systems.
• Ensure implementation of robust environmental monitoring and sterility assurance programs.
• Lead expansion projects, facility upgrades and new line implementation as per USFDA and EU GMP expectations.
• Drive automation, digitalization and operational efficiency initiatives across plant operations.
• Review and approve URS, qualification protocols, layouts and engineering change proposals.
• Build and mentor high-performance cross-functional teams.
• Strengthen GMP and technical capability through structured training and succession planning.
• Foster a culture of compliance, accountability and continuous improvement.
• Strong knowledge of Annex 1, aseptic processing and sterile manufacturing regulations
• Proven experience handling regulatory inspections independently
• Expertise in quality systems, validation and manufacturing science
• Strong leadership, decision-making and stakeholder management skills
• Exposure to SAP/ERP and digital manufacturing systems preferred

Job description

Key Responsibilities

Strategic & Operational Leadership

• Lead end-to-end plant operations including Production, Engineering, Warehouse, Utilities, Maintenance, EHS and Compliance functions.
• Drive operational excellence through productivity improvement, cost optimization, capacity enhancement and lean manufacturing initiatives.
• Ensure uninterrupted manufacturing operations with high equipment uptime, robust maintenance systems and effective resource utilization.
• Establish manufacturing strategies aligned with business growth and regulatory expectations for global markets.

Regulatory Compliance & Quality Systems

• Ensure sustained compliance with current cGMP requirements of USFDA, EMA, MHRA, PIC/S and WHO.
• Lead and manage regulatory inspections, customer audits and corporate audits with strong compliance outcomes.
• Drive implementation of Contamination Control Strategy (CCS), Quality Risk Management (QRM), Data Integrity and Quality Culture initiatives.
• Ensure effective investigation systems for deviations, OOS/OOT, CAPA, change control and risk assessments.

Sterile Manufacturing & Technical Oversight

• Provide technical leadership for aseptic processing, lyophilization, terminal sterilization and visual inspection operations.
• Support technology transfer, process validation, cleaning validation, media fills and continued process verification activities.
• Oversee qualification and lifecycle management of equipment, utilities and computerized systems.
• Ensure implementation of robust environmental monitoring and sterility assurance programs.

Projects & Engineering

• Lead expansion projects, facility upgrades and new line implementation as per USFDA and EU GMP expectations.
• Drive automation, digitalization and operational efficiency initiatives across plant operations.
• Review and approve URS, qualification protocols, layouts and engineering change proposals.

People Leadership

• Build and mentor high-performance cross-functional teams.
• Strengthen GMP and technical capability through structured training and succession planning.
• Foster a culture of compliance, accountability and continuous improvement.

Desired Competencies

• Strong knowledge of Annex 1, aseptic processing and sterile manufacturing regulations
• Proven experience handling regulatory inspections independently
• Expertise in quality systems, validation and manufacturing science
• Strong leadership, decision-making and stakeholder management skills
• Exposure to SAP/ERP and digital manufacturing systems preferred