Job Summary
Main Purpose of Job
- Facilitate the release of pharmaceutical and medical device products for sale, ensuring alignment with commercial objectives and ISO13485 requirements.
- Ensure the availability of standards and columns for product testing.
- Compile, review, and maintain Standard Operating Procedures (SOPs) and the SOP dashboard in line with ISO 13485 documentation requirements.
- Manage courier services for samples, documents, and related parcels.
- Oversee master batch documents, executed batch documents, and retention samples.
- Assist in implementing and managing an effective Quality Management System in accordance with ISO 13485.
- Maintain Artwork, Stability Data, and PQR data Smartsheet’s.
- Apply for permits as needed and request samples from Third-Party Distributors.
- Assist with tender applications.
- Assist with payment requisitions.
- Invoice review and payment requests.
- Any admin task pertaining to Quality Assurance or Regulatory Affairs
- GMP/GWP/GDP adherence
Key Performance Areas
- Ensuring Compliance with Legislation
- Managing Quality Standards
- System Implementation
EDUCATION
EXPERIENCE.
- Experience in an administrative role would be advantageous.
SKILLS/PHYSICAL COMPETENCIES
- Intermediate proficiency in Microsoft Office