QA and Regulatory Officer

2 weeks ago


Centurion, South Africa Sentinel Staffing Services Full time

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

- For more information please contact:
**Michelle



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