pharmaceutical company in seeking a Medical Affairs Manager within the Oncology and Haematology division. Represent medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas. Provide medical advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance expert medical/scientific advice for assigned products and related therapeutic areas, including responding
pharmaceutical company in seeking a Medical Affairs Manager within the Oncology and Haematology division. Represent medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas. Provide medical advice / guidance to key customers for assigned products and relevant therapeutic areas, including scientific Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance expert medical/scientific advice for assigned products and related therapeutic areas, including responding
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
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
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