Job Description

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

The main purpose of the Production Manager is to manage the Production department, ensure adherence to GMP and fulfil the production plan.

• General Duties
• The duties of Production Manager are defined according to SA GMP Guide.
• Ensure the timely supply of quality product to our customers
• Ensure that production relevant documentation is GMP compliant, on-time and reviewed prior to approval
• Ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality
• Implement/support risk-based approaches for all manufacturing aspects, operations and equipment within the department
• Oversee the development, implementation of and the adherence to the Standard Operating Procedures (SOPxe2x80x99s) in the department
• Ensure the areas of the department meet hygiene and cleanliness standards i.e. ensure that cleaning is appropriate and efficient according to production needs
• Ensure appropriate validation for equipment and processes are performed in the area of responsibility
• Ensure that adequate maintenance is carried out on all equipment, utilities and the manufacturing areas
• Support QA in all department-relevant quality investigations, for example product recalls, complaint investigation, deviations, OOS and change controls
• Ensure that there is a system in operation within the department to facilitate the inspection, investigation and taking of samples in order to monitor factors which may affect product quality
• Represent the department during inspections and audits

*

Budget & Cost Control * Develop and control the financial budget for the department

• Control and optimise the cost within the department
• Set quality and performance KPIxe2x80x99s for the department and monitor the departmental performance on a defined frequency
• Continuously improve processes to introduce World Class Manufacturing practices within the business
• Develop strategic roadmap for the department to meet market and business requirements for the present and future conditions
• Identify opportunities for productivity and efficiency improvements. Included in this will be the improvement of product yield.

People Management * Manage all personnel in the department and provide ongoing performance feedback to staff as and when required

• Ensure that all personnel in the department is developed and trained as required by the various job functions
• Ensure best working practices within the department
• Set quality and performance KPIxe2x80x99s for the department and monitor the departmental performance on a defined frequency

Quality Management * Oversee the development, implementation of and the adherence to the Quality Management System for the department

• Ensure compliance to all QM controlled processes and documents
• Represent the department during inspections and audit

• Scientific degree; preferably B. Pharm/BSc. Micro/ BSc Operations Management/ BSc Industrial Engineering
• At least 10 years production experience as production manager on Senior Management Level
• Production Manager experience in a sterile manufacturing environment
• Strong management experience
• Strong manufacturing process understanding
• Experience in continuous improvement techniques
• Can-do attitude

Fresenius Kabi