Aseptic Production Team Leader

2 months ago

Tianjin, Tianjin, China Novo Nordisk Full time

Company Overview

At Novo Nordisk, we pride ourselves on being a leading global healthcare company, dedicated to improving the lives of people with chronic diseases. Our commitment to excellence is reflected in our manufacturing facilities, which are recognized for their outstanding work environment.

Qualifications

Educational Background


• Bachelor's degree in microbiology, mechanical engineering, industrial engineering, chemistry, pharmacy, or biosciences. Advanced degrees are advantageous.


• Training in Good Manufacturing Practices (GMP) or International Organization for Standardization (ISO) is essential.


• Proficient in both written and spoken English.

Professional Experience


• A minimum of 3 years of experience in project management or production.


• At least 2 years of supervisory experience.


• Experience working within cross-functional teams is preferred.


• Direct experience in validation processes, including equipment and procedures, is a plus.


• Experience in aseptic production within the GMP-regulated pharmaceutical sector or life sciences is preferred.

Key Responsibilities

As a supervisor, you will oversee the execution of the Environmental Monitoring and Cleaning program.

The success of this role will be evaluated based on:


• The quality, timeliness, and budget adherence of project and routine implementations.


• The capability to provide process support.

Within your area, you will ensure successful qualification and routine operations while maintaining compliance with regulations and business standards.

Main Duties


• Manage the staffing plan for the Environmental Monitoring Operations team, ensuring effective deployment of personnel for routine operations and daily management.


• Oversee recruitment processes.


• Organize initial training sessions, develop training matrices, and ensure all personnel receive necessary training.


• Collaborate with other teams to prepare and update Standard Operating Procedures (SOPs) for your area, reviewing and approving documents as needed.


• Conduct performance evaluations for operators.


• Ensure strict adherence to aseptic behavior requirements among operators.


• Verify compliance with SOPs regarding cleaning and sampling processes.


• Ensure accurate and timely logbook entries by the operator team.


• Monitor compliance with SOPs for upgrading or degrading classified areas.


• Ensure cleaning of classified areas during emergencies follows SOP requirements.


• Prepare and deliver training on relevant topics.


• Support the efficient use of materials, finances, and personnel resources, contributing to budget establishment for the area.


• Collaborate with support teams to identify root causes of issues.


• Act as the Environmental Health and Safety (EHS) representative for the Environmental Monitoring department, working with management to ensure effective health and safety practices.


• Perform other tasks as assigned.

Decision-Making Authority

Decisions are made independently within the framework established by the management team.

Independence and Initiative

A high level of independence is expected in daily tasks, with a focus on facilitating processes and promoting innovative solutions.

Stakeholder Interaction

Regular communication and coordination with other departments, including Quality Assurance, Quality Control, and Facilities, is essential.

Impact on Results

As a team leader, you will significantly influence the production department's ability to maintain a secure production environment.

Communication Skills

Effective communication and coordination with management and other departments are critical for success in this role.

We are committed to an inclusive recruitment process and equal opportunity for all applicants. At Novo Nordisk, we strive to be the best company for the world, fostering a diverse and inclusive culture that celebrates the unique perspectives and backgrounds of our employees.

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