The purpose of the position is to assume the responsibility for all production operations within the Small Volume Parenteral (SVP) Department.
1.To ensure that the Small Volume Parenterals Department can meet its production requirements (in respect of volume, quality, costs) effectively and efficiently at all times.
2.To assist with production planning and to commit the Small Volume Parenteral department to maximum possible attainment of that plan.
3.To ensure optimum labour utilization whilst organizing and controlling the day to day production requirements of the various operations within the Small Volume Parenterals Department
4.To prepare the annual department budget and to monitor and control adherence to that budget
5.To ensure departmental compliance to the Guide to Good Manufacturing Practice for medicines in South Africa and PIC/S Standards
6.Ensure that the Department meets hygiene and cleanliness standards i.e.. Ensure that cleaning is appropriate and efficient according to production needs and GMP standards.
7.With support of Validation Department ensure that appropriate validation and calibration for equipment and processes are performed in the area of responsibility.
8.Support and carry out all relevant QA investigations by way of Root Cause Analysis, Risk Assessment, CAPA definition such as for product recalls, complaint investigation, deviations, OOS, OOT, change controls, PQR and Quality Risk Management.
9.To write, review and update (annually) the department’s Standard Operating Procedures and Good Manufacturing Practices.
10.Implement risk-based approaches for manufacturing aspects, operations and equipment specific to the Small Volume Parenteral Department.
11.Ensure that the final products meet specified quality.
12.Ensure that adequate maintenance is carried out on all equipment, utilities and the manufacturing areas of the Small Volumes Parenteral Department.
13.To control the drawing up and maintenance of all departmental production documentation and schedules (e.g. Batch books, logbooks)
14.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.
15.To control department staff discipline including settlement of problems/disputes and grievances; disciplinary matters; absenteeism; access control and time – keeping according to the Company Code of Conduct.
16.To commit the department to a comprehensive and on-going Training Program
17.To ensure the provision of timeous and accurate operational data (both routine and on-request) as required for the monitoring of key indicators.
18.To ensure the timeous reconciliation of batch documentation and transfer of product to the stores
19. Strive for continuous improvement of shop floor communication through regular shop floor meetings and department meetings.
20. Provide support with the execution of Continuous Improvement projects, by generating a positive impact on business mainly within the context of safety, quality, delivery and cost.