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

- Robust leadership, decision-making and stakeholder management skills

- Exposure to SAP/ERP and digital manufacturing systems preferred

📌 Plant Head - Sterile Injectables (Bawal)
🏢 Getwell Pharmaceuticals
📍 Bawal