Experience

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  Aspen South African Operations

  • South Africa
  • Pharmaceutical Manufacturing
  • 300 - 400 Employee

  • Quality Systems Team Lead

    • Jul 2023 - Present

    Responsible for coordination of QS activities which include Quality Risk Management, root cause analysis and product failures; interpretation and implementation of procedures, standards and specifications; coordination of APQR management and customer complaints

  • After Market Pharmacist

    • Feb 2020 - Jul 2023

    • Establishing, implementing and overseeing effective systems, processes and controls• Implementing and maintaining an effective system for conducting annual product reviews (APQR) • Compiling annual product quality review reports for all products commercially manufactured at two sterile manufacturing sites • Verifying the consistency of existing processes and the appropriateness of current specifications• Highlighting any trends; identifying product and process improvements• Compiling and maintaining standard operating procedures (SOP)• Investigating customer complaints and adverse drug reactions• Performing complaint categorisation and customer complaint trend analysis• Identifying and initiating corrective and preventative actions (CAPA) associated with any adverse trends • Performing as a strong member of a cohesive team with strict adherence to GMP guidelines, local and international regulations, as well as internal business requirements

  • Project Manager

    • Jul 2015 - Jan 2020

    • Managing new product developments, intellectual property upgrades, product and process optimisations, as well as technology transfers for local and international products• Managing numerous oral solid dosage forms as well as injectable products and eye drops intended for submission to major markets such as USA, EU, Brazil, Australia, China and South Africa• Coordinating activities of a diverse group of teams including analytical, raw material departments, regulatory, technical support and production• Ensuring timeous and successful completion of product developments, upgrades and technical transfers• Costing technical projects, preparing project quotes, tracking costs and forecasting for budgeting purposes• Generating and monitoring project plans and timelines • Coordinating efficient exchange of information and alignment between sending and receiving sites• Applying innovative and logical problem solving to resolve project related issues• Managing document exchange during and after transfer• Performing as a strong member of a cohesive team with strict adherence to health, safety and statutory regulations, service level agreements, quality standards, governance processes and compliance requirements• Participating in an optimisation workshop in India, to optimise and align project management practices between PM teams

  • Technical Support Pharmacist

    • Apr 2008 - Jun 2015

    • Providing technical and scientific support for internal and external technology transfer of manufacturing processes, for oral solid dosage forms• Extensive experience in the planning and manufacture of formulation development trials, as well as scale-up of manufacturing processes to support oven to fluid bed manufacturing process change • Participating in product reformulation studies to optimise performance of problematic products, using quality by design (QbD) principles• Providing remote assistance to the manufacturing facility in Germany to prepare QbD report, to support a product line extension submitted to several authorities including EU, Australia, Brazil, Mexico, Canada, USA and South Africa• Conducting technical feasibility assessments to evaluate manufacturing feasibility of new products prior to introduction and transfer• Providing technical support to granulation, compression and coating departments • Compiling technical documents to support regulatory submissions• Reviewing and analysing batch and product data to establish product quality target product profile, product quality attributes and critical process parameters• Developing strategies to ensure product quality, safety and efficacy throughout the product lifecycle

  • Production Pharmacist

    • Jan 2005 - Mar 2008

    • Planning batches in the department • Supervising staff during shift• Overseeing critical processing steps and ensuring correct documentation• Checking equipment cleanliness prior to batch manufacture• Checking materials against batch manufacturing document prior to use• Performing quality checks on coated tablets • Performing as a strong member of a cohesive team with strict adherence to GMP guidelines, local with a background in and international regulations, as well as internal business requirements

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  Department of Health South Africa

  • Frontier Hospital Queenstown

    • Jan 2004 - Dec 2004

    Community Service Pharmacist