QA and Regulatory Officer
2 weeks ago
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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