Hazel Dlamini Email & Phone Number

Cnr 15Th & Pharmaceutical Roads | Midrand | Gauteng | South Africa | 1685

West Rand Robertville

Compiling the Batch Manufacturing Instruction document for complimentary and registered product.Ensure authorization of Batch Manufacturing Instruction document (Bulk and Packing document) by Responsible Pharmacist and by the Applicant prior to use.Compiling Raw Material and Final Product according to the latest Pharmacopoeia or according to applicant request.Ensure that the Specifications are approved by the Applicant prior to use.Initiate the Stability study protocols and circulate them to Quality System Manager and Laboratory Manager. Maintain and update the Stability Study Programme for all Applicants. Compiling and Updating the Technical, Quality and Confidential Agreement for both new and existing Applicant.Ensure to obtain the latest Dossier Documentation or Technical information from Applicants, when generating documentation for new product.Conduct Annual Product Review for all Technikon Laboratories registered product.Assign codes (in conjuction with Purchasing) to all new product and components.Perform routine filling of approved documentArchive obsolete and superseded documents.Distribute Standard Operating Procedure and liaise with Training officer regarding S.O.P training required.

West Rand, Industria West

Compiling Raw material specification and testing method according to latest Pharmacopoeia.Compiling Final Product specification as per Dossier and according to latest Pharmacopoeia.Allocation of item codes to new packing component, raw material, bulk products and packed products.Loading of codes on SysproIssuing updated documents to the relevant departmentUpdating the Approved Manufacturing List on a regular basis.Production planning using Syspro and liaising with Planner during planning process. Receiving new dossiers from applicants and ensuring that all dossier documentation is filed and archived in a safe.Initiation of costing process by distributing the information to the relevant department.Reviewing Packing Specification, Packing documents and Bulk documentation.Reviewing the Standard Operation procedures (S.O.P), updating the S.O.P as per current MCC Guidelines, Pharmaceutical Guidelines and FDA requirements.Liaising with the applicants for additional information, if required.Coordinate the Deviations process on the following documentsApplication of ISO 9001:2008 system, WHO requirements in Documentation system.CAPA coordination and documentation coordination.

Commando Road, Industria West, Florida

Chemical and Microbiological analysis of: (According to relevant specification- BP, USP, In-house, Applicant or Supplier spec): Raw materials, Finished Product (Liquid, creams, ointments, Solids and sterile), stability samples and validation batches and customer complain samples according to Standard Operation Procedures. Operation of Instrument: GC, AA, UV-VIS, FTIR (Liquid and powder), Dissolution, Polarimeter, Refractometer, Melting point , Viscometer, pH meter, Tablets hardness tester, Disintegration tester, Karl Fischer, Particle size analyzer and calibration of Balances.Documentation: Complete all documentation thoroughly without errors; highlight any deviations and non-conformance on the Laboratory report. Maintain log book for equipment and laboratory system. Ensure that analytical results are records on trend card as per S.O.P. Report non-conforming results immediately to Lab Supervisor and troubleshoot where necessary. Initiate and complete Out of Specification investigation report as per S.O.PKey Competencies: Analytical chemistry (Wet chemistry, method development, data analysis, S.O.P development, investigations, organic and inorganic chemistry testing), Potentiometric titration. Ensure volumetric solution and standard solution are prepared, standardized and labelled as per S.O.P, ensure calibration of analytical equipment maintenance of calibration records, use valid reference standard for all analysis, assist the QC Manager with investigations, priorities analysis according to production planning for the day, application cGMP and cGLP, and good housekeeping and lab equipment maintenance.Health and Safety: Ensure to wear proper safety/protective wear at all times, ensure to take special precautions when working with hazardous chemicals. Ensure that chemicals spills are attended to immediately and cleaned up in the correct manner as per S.O.P. Ensure reagents stored are clearly marked to prevent mistake.

Bachelor’S Degree, Quality

Activities and Societies: Compilation of Thesisi: Assessing the Environmental Impact caused by Pharmaceutical Waste. Modules: Quality.

Matric, Science

National Diploma In Biotechnology, Health Science Faculty

Activities and Societies: Report writing, Presentations, Fermentation Practical, Analytical Chemistry Practical, Biodiversity Practical.