QA and Regulatory Officer - - Centurion

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
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