Sterility Support & Validation Manager

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 Sterility Support & Validation Manager is the management of the validation section and co-ordination of the total validation project.

Responsibilities / Duties:

Validation Section Management

§ General Section Management, i.e., Activity planning, co-ordination, execution and control (Project Management)

§ Maintenance of department efficiency through principles of supervision and management.

§ Acting as communication link between staff members and other departments and Management

§ Management and oversight of technology transfer activities (e.g., a commission of a new product and design element responsibility).

Systems maintenance

§ Such that FKMSA is able to satisfy regulatory authorities and Inspection bodies of necessary validation measures for continued business and securement of new business.

Validation

§ Responsible for implementation of a Risk Based Approach to all Validation and Qualification activities.

§ Ensure that all Validation and Qualification activities are managed and carried out according to GMP requirements.

§ Prepare and manage the Validation Master Plan which includes all equipment and process validation, utilities, computers and other related areas.

§ Overall responsibility for the development, preparation and implementation of written procedures, URS, DQ, IQ, OQ, PC, protocols and reports relating to Validation, Qualification and Calibration, inclusive of production, warehouse and laboratories.

§ Liaison with QA and Regulatory Affairs Department regarding process /validation requirements and the co-ordination thereof.

§ Ensure all Validation activities are managed and carried out according to GMP requirements

§ Present and justify validation scope and documents to both internal and external auditors

System evaluation

§ General process evaluation. This includes reporting of observed deficiencies to the correct persons and follow – up on corrective action liaising with Production where necessary.

§ Monitoring and auditing compliance to both regulatory requirements and in-house standards regarding current Good Manufacturing Practices.

§ Shared responsibility for the investigation into and solution of process and quality problems as well as preventative planning and action.

§ Carry out other tasks within the department/ factory which are consistent with the grade, qualification and training of the incumbent.

Sterility Support

§ Managing the completion of the ongoing training courses to QC learners based on controlled and informational training content.

§ Ensuring support to the operational efficiency of the QA and QC department is maintained.

§ Ensuring that the ongoing training of sterile core personnel is maintained.

§ Ensuring the sterility support project timelines are adhered to.

Quality

§ Responsible to conduct investigations and root cause analysis through Kabitrack

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

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

Minimum Requirements:

• A Life Science or Engineering degree or equivalent.
• 5-10 years of direct Validation Management experience in the pharmaceutical industry.
• Project Management skills
• Understanding and network in Regulatory Authorities and Inspections
• Risk assessment and evaluation methodology
• Good Manufacturing Practice Regulations
• Procedures and Documentation
• Audit experience, initiating, performing and following up
• Financial skills to control and optimize costs
• Continuous improvement methods
• Validation & Qualification requirements