Sterile Technician

Overview

BUSINESS UNIT : SOUTH AFRICAN VACCINE PRODUCERS DISCIPLINE : QUALITY ASSURANCE

LOCATION : SANDRINGHAM

POSITION : STERILE TECHNICIAN

PAY GRADE : C2

REFERENCE NUMBER : CORPSAVP0824 / )

Key Job Responsibilities

• Ensure that utility systems are maintained in a state of compliance and reliably perform their validated function with maximum availability to support the different production areas.
• Execute planned preventative maintenance program on utilities equipment including the purified water system, clean steam generation distribution system, electrical reticulation system, transformers, emergency generation, chilled water plant, compressed air system, Air Handling Units (AHU), including dehumidifiers and Production equipment.
• Execute planned preventative maintenance on equipment within the sterile antivenom environment including the clean room filling area, compounding and preparation area, Water for Injection (WFI) plant, clean steam, particle monitoring system, as well as leak detection and packaging area.
• Arrange and manage specialist contractors to perform specific tasks that fall outside the scope of internal resources, including evaluation of alternative key suppliers.
• Coordinate continuous improvement initiatives to establish root causes on recurring maintenance problems and implement action plans to achieve long term solutions.
• Responsible for the review and development of planned preventative maintenance (PPMs) schedules in a quest to continuously improve the maintenance system.
• Drive planned preventative maintenance schedule.
• Participate in various quality system elements, including deviation management, root cause analysis, CAP management, change control, and quality risk management.
• Participate in validation activities within the area of responsibility to ensure that pharmaceutical systems DQC, IQ, OQ and PQ are complied with as per SAHPRA and other regulatory requirements.
• Ensure compliance with regulatory requirements with regards to Good Engineering Practices (GEP) and current Good Manufacturing Practices (GMP).
• Assist with the drafting and updating of relevant department SOPs in a timely manner.

Minimum requirements & key competencies

Enquiries may be directed NdabenhleNgongoma @ , e-mail application to

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