Sterility Support and Validation Manager

SUMMARY:
Our client in the Pharmaceutical Industry, is looking to employ a skilled and experienced Sterility Support and Validation Manager, to their team in Port Elizabeth.

An exciting career opportunity await you!

POSITION INFO:
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 and Qualification requirements.

• 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).

• Such that the company can satisfy regulatory authorities and Inspection bodies of necessary validation measures for continued business and securement of new business.

• 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.

• 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.

• Responsible to conduct investigations and root cause analysis through internal systems.

• 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 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.