Sterility Support & Validation Manager

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

General 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 the plant 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.

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 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 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

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