Website Cape Winelands District Municipality
The Cape Winelands District Municipality covers an area of 22 309 km2 and is divided into five subdistricts, each with their own local municipality. These are Stellenbosch, Drakenstein, Witzenberg, Breede Valley and the Langeberg. The district is the second most populace area in the Province, with 895 529 people calling the area home. Together with this, the citizens are also the largest economic contributers after the City of Cape Town. The region is famous for its spectacular scenery of beautiful mountains and valleys, and wine and fruit estates, all of which attract large numbers of local and foreign tourists.
QUALITY ASSURANCE
Product Release:
- Assist with any/all documentation relating to product release and the accurate capturing of records and data.
- Assist with the control and storage of release samples.
- Perform Lot release checks according to prescribed procedures to ensure GMP compliance.
- Assist with Data Logger handling and temperature monitoring activities.
Operational Activities:
- Assist with delivery of day-to-day Quality Assurance activities, ensuring adherence to plans and schedules.
- Assist with the accurate completion of all database entries, registers and forms.
- Assist with the compilations and/or reviews of departmental SOP’s.
- Assist with recording of CAPA’s, deviations and any other reports.
- Assist with quality related investigations.
- Assist with recording and arranging destructions as and when required.
- Liaise with suppliers as and when required.
- To carry out any other administrative duty as and when required
- Assist with annual reviews per product including but not limited to report preparation, sample inspections and supplier requests.
- Assist with tracking, communication, and support of annual QA plan activities.
- Assist with review of laboratory and/or stability results.
REGULATORY AFFAIRS
- Assist with the registration process and commercialisation of Complementary products in consumer portfolio
- Align all Complementary product dossiers across all markets
- Update the SAHPRA CAMS licence (3D-licence) when required – New CAMS products or changes to existing products
- Compile and submit all responses to Regulator queries, safety updates and variations, within agreed and specified time limits.
- Maintain the department’s online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions.
- Review product artwork and ensures compliance with registration and labelling regulations of Medicines and Related Substances Act 101 of 1965.
GENERAL
Good Manufacturing practice (GMP):
- Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements.
Training:
- Attend and/or present training sessions as and when required
Requirements
PRE-REQUISITES
- Bachelor’s degree in relevant scientific discipline.
- Proven experience in quality assurance and/or regulatory affairs within the pharmaceutical industry (advantageous).
- Strong knowledge of GMP and GDoc practices, including SAHPRA and international guidelines.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments.
- Detail-oriented with strong analytical and problem-solving abilities.
- Demonstrated ability to drive continuous improvement and implement best practices in quality assurance