To assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements and those Complaints Investigations, PQR's, Quality Risk Management) To review and authorize Non-conformance Reports to the business by timeous review of products for release. Product Release and Supply: to ensure timeous warehouse; to assess laboratory requirements for new product analysis; to assist in reviewing the monthly Schedule set-up laboratories in advance of delivery of product; to compile the Monthly Metrics report on all Quality
To assist and maintain aspects of the Quality Management System, adhering to SA GMP requirements and those Complaints Investigations, PQR's, Quality Risk Management) To review and authorize Non-conformance Reports to the business by timeous review of products for release. Product Release and Supply: to ensure timeous warehouse; to assess laboratory requirements for new product analysis; to assist in reviewing the monthly Schedule set-up laboratories in advance of delivery of product; to compile the Monthly Metrics report on all Quality
and Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory Responsibilities: Manage work streams for- and report on the assigned portfolio of products: Assisting with with internal product queries from relevant departments Assisting with external product queries from the standards Co-ordination and submission of new product applications in South Africa and other applicable plans for the preparation and submission of new products Conduct dossier due diligence to ensure all data
Strategic support for new launch & existing products – medical/scientific strategy for new launches launches and strategic LCM inputs for existing products Providing leadership and strategic direction for interactions advisory boards or roundtables to build and reinforce product awareness and gain strategic insights for medical end-to-end management and execution. Evaluation of New Products Evaluation of new products - identifying identifying products to enable the building of a robust portfolio Providing medical rationale & analysis
work) to perform chemical testing on Finished Product and Water Samples. Key Responsibilities: Ensures Ensures that the samples received agree to the Production Program and label copy Ensures the correct procedures are sampled and tested timeously Tests finished products using current pharmacopoeias/SOP associated with and reports failing results to the Supervisor. Manager during failures Ensures that equipment is calibrated results are acceptable and liaises with Supervisor / Manager to determine if resampling / retesting is required
work) to perform chemical testing on Finished Product and Water Samples. Key Responsibilities: Ensures Ensures that the samples received agree to the Production Program and label copy Ensures the correct procedures are sampled and tested timeously Tests finished products using current pharmacopoeias/SOP associated with and reports failing results to the Supervisor. Manager during failures Ensures that equipment is calibrated results are acceptable and liaises with Supervisor / Manager to determine if resampling / retesting is required
the following: Detailing and promoting oncology products, in a designated areas, to private and public-sector organizing and presentation of divisional activities, product launches, conferences, speakers programs and other all targeted clients. Liaising with the Sales Manager with respect to the effective exploitation of the ensure market penetration. Able to efficiently manage budget and resources within the scope of the business ability to sell products and achieve sales targets. Demonstrate the ability to learn product/disease entity
for the overall management of Change Controls within the Group, Assist Senior QA Manager with the rollout required data in order to effectively coordinate and manage the proposed change. Document the rationale for and change control procedures. Support with the management of SOP's and training in the eDMS and eLMS systems compliance to SOPs and management of the TrackWise systems (Deviations, CAPAs, Product Quality Complaints) specified timelines Forwarding of all received Product Quality Complaints, Adverse Events and Medical
for the overall management of Change Controls within the Group, Assist Senior QA Manager with the rollout required data in order to effectively coordinate and manage the proposed change. Document the rationale for and change control procedures. Support with the management of SOP's and training in the eDMS and eLMS systems compliance to SOPs and management of the TrackWise systems (Deviations, CAPAs, Product Quality Complaints) specified timelines Forwarding of all received Product Quality Complaints, Adverse Events and Medical
applicable), including the South African Health Products Regulatory Authority (SAHPRA) and South African Assisting with internal product queries from relevant departments Effectively managing activity within Regulatory experience with MS Office, Document Management System and / or Quality Management Systems. Competencies: Attention Attention to detail IT skills, document management skills Project management skills Good language skills Ability