QA and Regulatory Officer

Description:

Our client is a well-established medical group of companies in Irene, Centurion. They are looking for a QA and Regulatory Officer to join their dynamic team. Qualifications:
Tertiary degree required in the Natural Sciences or Engineering
Minimum of 2 Years working experience

Competencies:

• Good communication skills in writing, presentation, and interpersonal communication (Good writing skills is essential)
• High ethical standards
• Good understanding of statistics
• Computer literate: Microsoft Office

Primary Responsibilities:

• Develop validation protocols and reports encompassing process, packaging, sterilization, and equipment validations, ensuring compliance.
• Maintain document control for all materials used in the quality management system.
• Conduct quality reviews of documentation, including procedures, forms, and records.
• Coordinate the resolution of non-conformances by collaborating with relevant departments, documenting processes, and ensuring evidence inclusion.
• Oversee process risk management and document all preventive actions as required.
• Conduct internal audits within the department.
• Assist in facilitating third-party audits as instructed by the department manager.
• Assist in organizing supplier audits as directed by the department manager.
• Identify areas for enhancing the quality management system and facilitate necessary actions.
• Provide regulatory support for product development, including assisting in technical documentation and clinical evaluations.
• Deliver and coordinate training on quality processes and procedures for staff.
• Support day-to-day tasks associated with maintaining QMS compliance.

Working hours are Mondays to Fridays from 07:00 to 16:00 (With overtime on demand)
The role is available to start as soon as possible, preferably by 1 June 2024
.

Requirements:

• Good communication skills in writing, presentation, and interpersonal communication (Good writing skills is essential)
• High ethical standards
• Good understanding of statistics
• Computer literate: Microsoft Office

• Develop validation protocols and reports encompassing process, packaging, sterilization, and equipment validations, ensuring compliance.
• Maintain document control for all materials used in the quality management system.
• Conduct quality reviews of documentation, including procedures, forms, and records.
• Coordinate the resolution of non-conformances by collaborating with relevant departments, documenting processes, and ensuring evidence inclusion.
• Oversee process risk management and document all preventive actions as required.
• Conduct internal audits within the department.
• Assist in facilitating third-party audits as instructed by the department manager.
• Assist in organizing supplier audits as directed by the department manager.
• Identify areas for enhancing the quality management system and facilitate necessary actions.
• Provide regulatory support for product development, including assisting in technical documentation and clinical evaluations.
• Deliver and coordinate training on quality processes and procedures for staff.
• Support day-to-day tasks associated with maintaining QMS compliance.