Production Team Leader

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
The Production Team Lead position at Baxter Healthcare Corporation provides an outstanding chance to lead and encourage a committed compounding team in our TPN LAF and Pharmacy CDSC Suites. You will ensure our manufacturing systems operate at the highest standards.

QUALIFICATIONS:

• Certificate or Diploma in Science or a related field.
• Previous experience in a GMP healthcare production environment or aseptic pharmaceutical production in a hospital or industrial setting.
• Experience working in aseptic manufacturing.

THE TEAM LEAD IS ACCOUNTABLE FOR THE FOLLOWING ACTIVITIES:

• Operation and promotion of workflow through CNC, Grade D, Grade B, and Inspection and Labelling rooms.
• Observing daily activity and actively promoting Good Manufacturing Practices.
• Ensuring all team members align with SOPs, GMP/GDP, and EHS requirements.
• Demonstrating outstanding leadership and coordination of staff members according to production workflow:
  Chemotherapy, Antibiotics, and aseptically filled devices using Cytotoxic Drug Safety Cabinet (CDSC) technology.

1. Total Parenteral Nutrition (TPN) using Laminar Air Flow (LAF) Cabinet technology.

• Coordinating workflow, allocating jobs, and managing any urgent or short-expiry stock.
• Identifying, reporting, and advancing any issues, faults, or non-conformances to Operations Supervisors and Quality personnel.
• Raising quality incidents on Baxter’s internal system (CQI database) and liaising with Quality on issues, maintaining and developing GMP within the production area.
• Assisting in investigating, identifying, and implementing corrective actions for non-conformances.
• Coordinating and performing staff training.
• Performing daily checks and sign-offs on GMP documentation.
• Assisting in process and equipment validation as per procedures and approved protocols.
• Liaising with the Operations Leadership team for production planning, scheduling, maintenance, and cleaning requirements.

The Team Lead can perform the following tasks in the Grade B LAF or CDSC rooms:

OTHER RESPONSIBILITIES:

• Deputising for Supervisor(s) when required.
• Working within their area of expertise.
• Identifying training needs.
• Undertaking tasks as assigned by the line manager.
• Aligning with Environmental Health and Safety (EHS) requirements.
• Observing company rules and procedures.
• Performing any other tasks or activities required by the business.

When acting as Compounder, the Team Lead is responsible for:

• Ensuring accurate aseptic technique and process controls.
• Conducting compounding session cleaning checks and monitoring.
• Accurately setting up and using cabinet & equipment.
• Accurately sanitising and transferring materials and components.
• Adhering to all Pharmacy and TPN compounding procedures

When acting as Observer-Reconciler, the Team Lead is responsible for:

• Ensuring all operators adhere to compounding and clean room procedures.
• Ensuring accurate volumes, reconstitutions, dilutions, withdrawals, and additions for Patient Specific and Batch products.
• Completing manufacture system checks contemporaneously.
• Witnessing Compounder Grade A Hand, Surface, and Settle plate Environmental Monitoring (EM) sampling to ensure accurate technique.
• Observing Compounder Grade A end-of-day Media Fill to ensure accurate technique.
• Accurately sanitising and transferring materials and components into the cabinet without impacting aseptic compounding activities.
• Segregating materials, components, and waste in the cabinet appropriately.
• Mentoring operators in adherence to aseptic process controls and techniques, with the authority to raise deviations