Regulatory and Quality Assistant (Pharmaceutical)
A Pharmaceutical Company in the Centurion area has a vacancy for a Regulatory and QA Assistant.

The successful candidate will assist with the following:
All Regulatory issues i.e. with new registrations and dossier maintenance for compliance
Assist Responsible Pharmacist and Quality Control Pharmacist Role to ensure 100 % compliance in terms of GMP and with all SAPC, MCC and DOH requirements
Assist RP/QA Pharmacist with SOP maintenance and filing
Assist responsible Pharmacists with all filing and document control
Assist with CoA’s requested by Customers for sold products
Assist with Pharmacovigilance and responsible to do monthly Literature screening
Assist with filing of approved printed packaging material
Assist with controlled substances (INCB) Import and Export permits and quarterly and annual reconciliations
Assist with approval of printed packaging material e.g. proof reading
Assist with SEP requirements
Assist with Regulatory Change Controls from Principal and initiate local regulatory change controls
Assist QA Pharmacist with PQRs regarding the registration dossier
Assist with registration maintenance of registered products for compliance
Assist with Regulatory relevant SOP maintenance
Can assist Responsible Pharmacist with self-inspections
Assist with Regulatory Change Controls from Principal and initiate local regulatory change controls
Assist with Technical Queries
Can assist with Final Product Releases if and when the need arises
Assist the QA Pharmacist with the following: Post-importation readiness: Samples to 3rd party; Reference standard maintenance; Current Final Product Release Specs and Methods at laboratory
Can assist with customer returns which includes damaged / rejected products and Quality Management System trending
Assistance with all QA/RA filing and documentation control (electronic and hard copies)
Assistance with Pharmacovigilance filing, Training record maintenance
Typing of RA/QA documents
Assistance with Regulatory aspects of Artwork

Requirements
Matric
Own vehicle with valid Driver’s Licence
At least 2 years relevant Regulatory and Quality control experience
Knowledge and understanding of Medicine Registration process of MCC