Process Support Unit Lead

The Process Support Unit Lead is responsible for leading the process unit team in coordinating and planning all activities related to end-to-end manufacturing, including logistics, project work, operational excellence, resources, and budget/cost management. The role promotes a culture of self-direction, empowerment, and accountability.

Ensures full compliance with quality, health, safety, and environment (HSE) standards, Good Manufacturing Practices (GMP), customer service, statutory, and regulatory requirements.

Job Description

Major accountabilities:

• Transmit knowledge, skills, and information to team members regarding objectives, problems, performance indicators, values, and behavior.
• Monitor compliance activities necessary for the timely release of batches produced.
• Ensure processes adhere to cGMP and safety, health, and environmental regulations.
• Manage quality events within appropriate timeframes, including escalation, investigation, and impact assessment.
• Maintain validated manufacturing processes and qualified equipment with appropriate operational expertise resources.
• Support regulatory dossier preparation and submission, including product transfers and variations, and respond to health, safety, and environment authority questions.
• Oversee internal and external audits, GMP, and HSE inspections.
• Manage production documentation flow, including SOPs, MBRs, and forms.
• Ensure inspection readiness of the area of responsibility.
• Participate in defining operational improvement strategies and continuous improvement projects, prioritizing actions based on available resources.

Essential requirements:

• Scientific or engineering degree.
• Solid experience in manufacturing, QA, or engineering within a pharmaceutical company.
• Knowledge of assembly language, change control, chemical engineering, chemistry, continual improvement, process efficiency, HSE, GMP, lean manufacturing, process control, productivity, risk management, root cause analysis (RCA), Six Sigma, SOPs, teamwork, technology transfer, web methods, flow.

Key Skills

Employment Type: Full-Time

Experience: [specify years]

Vacancy: 1