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.Purpose of the role: To accept overall responsibility for the Large Volume Parenterals department such as filling, sterilisation and Prelim PackingGeneral Duties

• To ensure that the Large Volume Parenteral Department can meet its production requirements (in respect of volume, quality, and costs) effectively and efficiently at all times.
• To assist with production planning and to commit the Large Volume Parenteral department to maximum possible attainment of that plan.
• To ensure optimum labor utilization at all times whilst organizing and controlling the day to day production requirements of the various operations within the Large Volume Parenteral Department
• To ensure departmental compliance to the Guide to Good Manufacturing Practice for medicines in South Africa.
• Ensure that the Department meets hygiene and cleanliness standards ie. Ensure that cleaning is appropriate and efficient according to production needs and GMP standards.
• With support of Validation Department ensure that appropriate validation and calibration for equipment and processes are performed in the area of responsibility.
• Support and carry out all relevant QA investigations by way of Root Cause Analysis, Risk Assessment, CAPA for example: product recalls, complaint investigation, deviations, OOS, OOT, change controls, PQR and Quality Risk Management.
• Ensure that the final products meet specified quality.

• Ensure that adequate maintenance is carried out on all equipment, utilities, and the manufacturing areas of the Large Volumes Parenteral Department.
• To write, review and update (annually) the departments Standard Operating Procedures and Good Manufacturing Practices.
• Implement risk-based approaches for manufacturing aspects, operations and equipment specific to the Large Volume Parenteral Department.
• Ensure that the final products meet specified quality.
• Ensure that adequate maintenance is carried out on all equipment, utilities and the manufacturing areas of the Large Volume Parenteral Department.
• To control the drawing up and maintenance of all departmental production documentation and schedules in full compliance with Good Documentation Practices (e.g. Batch Manufacturing Records, log books)
• To continuously strive to develop methods and systems for maintaining the highest possible quality of production, whilst optimizing maximum efficiency of company resources with minimal reject and waste levels.
• To ensure the provision of timeous and accurate operational data (both routine and on-request) as required for the monitoring of key indicators.
• To ensure the timeous reconciliation of batch documentation and transfer of product to the stores.
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Budget and Cost Control

• Control and optimize the cost within the department
• Set quality and performance KPIs for the department and monitor the departmental performance on a defined frequency
• Continuously improve processes to introduce World Class Manufacturing practices within the business
• Identify opportunities for productivity and efficiency improvements

Human Resources Management * Manage all personnel in the department including disciplinary procedure

• Ensure that all personnel in the department is developed and trained as required by the various job functions
• Recruitment of staff
• Staff development regarding identifying needs and opportunities
• Performance Management evaluation
• Review salaries and promotions if applicable
• Implementation of equity plan as set out in the Employment Equity Policy

• Appropriate tertiary qualification with minimum Bachelor of Pharmacy / BSc Microbiology, or similar degree in Production/Operation Management fields.
• Minimum 7 years experience in a sterile, pharmaceutical production environment with at least 3 years at management level.
• Previous, relevant pharmaceutical or manufacturing experience
• Strong managerial experience
• Strong maintenance and technical knowledge

Fresenius Kabi