Experience

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  PHARMACEUTICAL CONTRACTORS

  • City of Johannesburg, Gauteng, South Africa

  • Validation Manager

    • Jul 2022 - Present
    • City of Johannesburg, Gauteng, South Africa

    • Responsible for designing the validation system and ensuring appropriate validation policies and procedures are in place within the Quality Management System (QMS).• Responsible for maintaining and continually improving validation policies and procedures within the QMS in-line with current national and international standards.• Responsible for reviewing and maintaining the Validation Master Plan (VMP) for the Production and Quality Control areas of the site. • Responsible for all equipment/instrument calibrations in the manufacturing area (internal and external).• Manage any contractors/temporary staff assisting with validation functions and to ensure that all assigned activities are conducted in accordance with regulatory requirements and GMP. • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.• Development and maintenance of risk management program (including dashboards, actions plan, indicators, risk-frameworks, metrics, and reports) in collaboration with cross functional teams.• Provide expertise in areas of risk management, risk analysis, statistics, problem solving, and continuous improvement approaches. • Application of Risk Assessment throughout project lifecycle focusing assessment to quality, efficacy, and safety• Providing of technical expertise and guidance on validation processes and qualifications and the implementation of those within the Production, Packaging, Engineering and Quality Control functional areas. • Involvement on projects to further develop quality surveillance, systems for risk-based decision support, risk analysis tools for quality, quality metrics and compliance• Development and maintenance of Computer Systems Validation ensuring all equipment is 21 CFR and GAMP 5 compliant.

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  Pharmachem Laboratories (Pty) Ltd

  • Validation and QMS Officer

    • Oct 2021 - Jul 2022

    • Generation, execution and management of a validation system and plan including generation of qualification protocols retrospectively due legacy equipment and prior being only CAM’s production• Retrospective process validation on legacy and existing• CAM’s products for registration of existing products• Stability and hold time protocol generation, execution and submission for Regulatory Review and Approval• Introduction of Quality Risk Management procedures for the transition of CAMs to registered pharmaceutical products• Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity and other factors.• Aligning the new product development team with technology transfer processes by generation, execution and management of site transfers of products• Implementation of cleaning validation program by risk-based approach as no prior validation was conducted• Identified causes of equipment failures and made suggestions for issue resolution.• Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.

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  Cipla

  • India
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Validation & Tech. Transfer Team Leader

    • Nov 2019 - Oct 2021

    • Re-introduction of various existing effervescent and liquid products back into the facility including the process validation and verification • Ensuring routine and commercial manufacture without any OOS / OOT)• Identifying and changing suppliers to assist in cost saving, providing fixed vendors for excipients when commercially manufacturing to mitigate the issuing of incorrect vendor material• Stability and hold time protocol generation, execution and submission for Regulatory Review and Approval• Generation, execution and management of a validation System and Plan including generation of qualification protocols• Knowledge and skills transfer to various user departments on the qualification process for equipment and utilities• Cross Functional Team Collaboration and Coordination to assist in equipment issues, statistical evaluation and process assistance, identifying negative trends and ways to decrease occurrence• Correcting dossier non-compliance through standardization for future CAM (complementary and alternative medicine) dossier implementation and submissions• Quality Risk Management throughout project lifecycle with a focus quality, efficacy and safety• Continuous development of scientific knowledge for self and facility through research and dissemination of information• Regulatory Affairs support through the provision of necessary validation including approval of change controls, non-conformances and Corrective and/or preventative actions (CAPAs)• Split delegation into management of personnel through delegation of tasks, review of performance through KPIs and prioritization/delineation of responsibilities• Managed the project of the relocation of the Quality Control Laboratory to the main building ensuring all equipment and AHU were requalified and calibrated• Managed the technology transfer of new product by Cross Functional Global Team Collaboration and Coordination to assist to ensure all gaps are identified

  • Quality Assurance Officer

    • Oct 2015 - Oct 2019

    • Surveillance of Regulatory Requirements as well as Communication to Key stakeholders to Maintain/Meet Compliance• Perform risk assessments to support innovation within the department regarding validation activities• Preparation and coordination of validation protocols and activities• Trending and reporting of available Data, Trend• Identification and CAPA implementation with Effectiveness Checks• Identification and Validation of Critical Quality• Attributes to improve/ensure quality of product Bulk Hold Time Study Protocol generation, execution and management to maintain compliance• Maintenance of the quality management system describing compliance with cGMP• Conducting QMS audits externally for Supplier• Qualification and Approval, and internally for quality improvements

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  Farm-Ag International

  • KwaZulu-Natal, South Africa

  • Laboratory Assistant

    • Jan 2015 - Sep 2015
    • KwaZulu-Natal, South Africa

    • Used standard analytical equipment such as high-performance and gas chromatographic techniques, viscometry, and particle size analyser• Devised and reworked formulations on a small scale for testing and trials conducted by the Research and Development department• Compliance management effectively keeping with GMP in the management of paperwork, analytical and numeric data• Improved the stability program and by ensuring timely analysis to keep in GMP standards.• Developed new analytical techniques and enhanced existing analytical methods to improve testing validity and applicability.• Performed standard and proprietary physical testing and chemical analysis of raw chemical materials and finished products