Posted on :
9 Aug, 2021
9 Aug, 2021
Fresenius Kabi is a global healthcare company with over 39 000 employees worldwide.
We offer employees of diverse cultures and backgrounds a wide range of fulfilling and challenging career and personal growth opportunities both domestically and internationally.
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.
Job Title: LVP Department Manager
Location: Port Elizabeth, Eastern Cape, South Africa
Reference #: 20210810
Contract Type: Permanent
Salary: Market Related
The ideal candidate for this vacancy will have extensive experience within the pharmaceutical production environment, a scientific degree (preferably B. Pharm) or tertiary degree in Operations Management, management experience and Green Belt Certification.
The main purpose of the position is to accept overall responsibility for the Large Volume Parenterals production, including the Filling, Autoclave and Prelim Packing departments.
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, Good Documentation practices and PIC/guidelines 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.
To write, review and update (annually) the department’s 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 (e.g. Batch books, 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
Manage matters emanating from system reports
Develop teams and team members:
Set update and monitor achievement of individual goals/KPI’s
Coach and train/arrange training of team members
Develop competencies of team members
Conduct career discussions with team members
Budget and Cost Control:
Control and optimise the cost within the department
Set quality and performance KPI’s 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
Manage budget and expenditure
oParticipation in budget development, monitoring and control for area of responsibility
oAdhering to procedures for stock and non-stock acquisitions
Human Resources Management:
Manage all personnel in the department including disciplinary procedures
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
From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumben
Scientific degree; preferably B. Pharm or tertiary degree in operations management
Green Belt Certification is desirable
Minimum 7 years’ experience in a pharmaceutical production environment with at least 3 years at management level.
Strong previous managerial experience
Strong maintenance and technical knowledge
Application Deadline: 20/08/2021