1 Scientific Affairs jobs in South Africa
Scientific affairs scientist
Pharma Dynamics
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Job Description
QUALITY ASSURANCEProduct ReleaseAssist 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 ActivitiesAssist 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 AFFAIRSAssist 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 (3 D-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, docu Bridge, 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. GENERALGood Manufacturing Practice (GMP)Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements. TrainingAttend and/or present training sessions as and when required #J-18808-Ljbffr
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