QA and Regulatory Officer

3 weeks ago


Centurion, South Africa Sentinel Staffing Services Full time
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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