Risk and Change Management Officer
About the role
To initiate, implement and manage THE CLIENT’S formal Quality Risk Management program and strengthen and maintain the Change Control system implemented at THE CLIENT in line with industry practices and regulatory expectations.
To support THE CLIENT’S mission and vision and Quality Management System through the implementation and maintenance of a formal Quality Risk management program and Change Control system, ensuring adherence to the various strategic, business, cGMP and other requirements such as ISO13485 for Medical Devices.
• Bachelor’s Degree in Science, Biological, Chemistry, Pharmaceutical Sciences or related field
• A minimum of 3 years’ experience in pharmaceutical manufacturing with working knowledge of pharmaceutical quality risk assessments and change control, is required.
• 3 years’ experience in a role responsible for risk and change management.
• Experience with cGMP guidelines pertaining to the Pharmaceutical industry.
• Knowledge of ICH Q9, ISO13485 and ISO14971 would be an advantage.
• Working knowledge of the SAP business system would be an advantage.
• Fully competent in Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Power Point, and Microsoft Project.
• Must be able to interact effectively with a variety of individuals and personalities within
and between departments and customers.
Specific Operational Requirements
• The successful candidate will be required to work an 8-hour day between 08h00 to 16h00
• The successful candidate may be required to work overtime to meet the business need
Key Performance Areas
• Design, implement and maintain the Risk Management programme
• Manage the Change Control system
• Risk Management and Change Control monitoring and reporting
• Business risk management
• Hands on experience with Quality Risk Assessments and Change Control procedures
• Working Knowledge of Risk Management guidelines and standards (e.g. ICH9, ISO 14971)
• Experience with electronic ERP systems such as SAP is preferred
• Robust working knowledge of Microsoft Excel and/or other trending tools
• Ability to work independently with minimal supervision
• Ability to work with individuals across all levels of the company, including management
• Strong analytical and problem-solving skills
• Quality awareness
• Good technical writing skills
• Excellent attention to detail
• Planning and organizing
• Leading with Integrity and Respect
• Results driven/ orientated
• Engaging and Inspiring
• Coaching and mentoring of others