Nolonwabo Malinge

•Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES
• Coordinates and supports administrative functions within QS
• QS coordination and support
• Provide QA IT systems support
• Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements
• Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions
• Master data management
• Define and manage critical data relating to quality
• Ensure adherence to product master data standards Master batch record (MBR) creation and validation
• Create new item IDs on the ERP
• Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system
• Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
• Ensure that MBRs are GMP compliant
• Ensure proper MBR change controls in process compliance Procedure and document compliance
• Implement quality manuals and policies
• Conceptualize, initiate and author SOPs and process documents Identify, process and store records and review output documents
• Conduct root cause analysis and risk assessments and report
• Participate in QMS monthly and annual reviews
• Request, allocate and monitor the use of MES related assets and resources for the fulfillment of work objectives

• Planning, co‑ordination and management of stability trials for the purpose of pharmaceutical product registration and registration renewals
• Investigate 100% Out Of Specification (OOS) generated during stability trials and implement CAPAs, achieving approximately 60% reduction in OOS's generated in the past 12 months
• Liaise with pharmacovigilance department in cases of confirmed product related OOS's, for the completion of Health Hazard Evaluations in order to ascertain patient safety. 100% of confirmed product failures being reported
• Foster regulatory compliance via the maintenance departmental procedures, In the past 12 months 2 minor audit finding and no major departmental findings in both internal and external audits
• As part of the internal audit team, conduct internal audits in accordance with ISO 9001 standards

• Recommend product‑specific improvements via Annual Product Quality Review compilations and reviews
• Verify site compliance to Good Manufacturing Practices by completions of departmental QA oversight walks and appropriate CAPA initiations
• Investigation of production deviations, Root cause Analysis and implementation of Corrective And Preventative Actions
• Investigations of customer complaints and Adverse Drug Reactions and provision of customer feedback in report formats
• Maintain compliance to Quality Management Systems
• Tutoring of pharmacist interns and Pharmacy assistants

• Perform line opening and line closure in dispensary, granulation, compression and coating departments
• Supervision and final sign off of each manufacturing step in the production process and BMR audit
• Investigations of production deviations and customer complaints as well as implementation of CAPA's and maintenance of QMS
• Maintenance of Standard Operating Procedures
• Working with production leaders on planning and execution of weekly and monthly targets

• Supervision and training pharmacy support personnel ensuring that all staff conducting work under the pharmacy act are registered.
• Analysis and dispensing of prescriptions in accordance to Standard Treatment Guidelines and supervision thereof
• Initiation and implementation of Ward‑pharmacist‑activities as well as chairing of Pharmaceutics and Therapeutics Committee meetings
• Maintain Standard Operating procedures and champion compliance thereof, The Pharmacy was awarded an A‑grade status following a South African Pharmacy Council Audit.

• Conducting on‑the‑job learning under the supervision of a pharmacist in order to fulfill the requirements for registration as a pharmacist with South African Pharmacy Council.