Quality Assurance Pharmacist (Fixed Term Contract)
We seek to employ a seasoned QA Pharmacist to ensure that all products are released according to GMP in compliance with the registration dossier and maintaining and implementing the Quality Management System. KEY RESPONSIBILITIESLot Release Conduct manage and coordinate Batch release reviews, manufacturing, packaging and analytical records and approve Final product release to the market as per the legal requirements and guidelines set by the SAHPRA and Department of Health in line with the registered dossier. Liaise and communicate any non compliances and discrepancies. Coordinate, review, monitor and approve to ensure compliance to the Quality Management System (QMS) and Good Manufacturing Practice (GMP) with regards to below but not limited to:o Change control processo Deviationso CAPA (Corrective and Preventive Action)o Issue logo Destructionso Investigationso Risk Assessmentso Temperature monitoring Ensure the timeous testing for post importation requirements and documentation thereof with contract laboratories Review and approve Bulk Material inspections before packaging and liaise with contractors and maintain registers Review and Approve final packed product inspection, maintains the product trend charts Ensure that the lot release register for all products are updated on an ongoing basis Investigate on-line issues and deviations at contractors to avoid an impact to quality and regulatory compliance of company products. Responsible for documented reporting in this regard and relating to lot release Preparation, compiling and maintenance and review of new business development projects (new product launches) Assist with reviews and updates as the need arisesGood Manufacturing practice (GMP, GLP, GWP) Always maintain and coordinate all the GMP principles as required by the SAHPRA as stipulated in the latest version of the SAHPRA / PIC/S (Pharmaceutical Inspection Co-operation Scheme) guidelines for cGMP and related systems and procedures to ensure compliance.New Product Launches Prioritize and coordinate the QA responsibilities for New Product Launches:o PTC Chartso Artwork reviewso Coordination (Lab, supplier, packer, distributor) Reviews and approve internal documentation that are drawn up for new productsDocumentation data base Maintain the contractor master documentation data base:o in-house master copies relating to lot releases and operational processes. Maintain the internal QA documentation data base ensuring that the company is in regulatory compliance with its current SAHPRA licensing conditions for manufacture, packing and testing (templates, forms, charts registers and reports) Update the company Electronic Document Management System with all relevant information Co-ordinate and monitor change controls through recording changes on a central document register and tracking it to implementation and close-out. Assist with the resolve and risk assessment and management of excursions to temperature monitoring results post importation. Review and approve artwork changes on registered products.Reports Compile monthly progress reports on all the principles within the GMP portfolio and on request from management Management reporting as required.Training Review, develop and conduct training w.r.t. operational support Ensure that training records are completed and are filed Supervise/manage/coach staff complement and related activities, if/when necessary
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Pharma Dynamics is a leading pharmaceutical company. We are one of South Africa's largest generic medicine providers and the country's leading provide...