Asavela Lengisi

at SafriCanna
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Location
City of Johannesburg, Gauteng, South Africa, ZA

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Experience

    • South Africa
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
      • Sep 2022 - Present

      Led SafriCanna team to successfully attain EU-GMP certification.Responsible for development and systemic implementation of Quality Management System based on current regulatory standards and expectations.Regulatory compliance - cGMP, EUGMP , GMP(PIC/S), CUMCS.

      • Jun 2021 - Sep 2022

    • Canada
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Compliance and Quality Assurance Manager
      • Apr 2019 - Mar 2021

      Compliance and Quality Assurance Manager for Africa Alignment and ensure ongoing compliance with Quality and regulatory requirements. Implementation of Quality Management system according to ISO standards. Ensuring that the food safety policy and the objectives of the FSMS are established and are compatible with the strategic direction of the organization. Development and implementation of QMS for Medical Grade and Hemp Cannabis Operations in Africa. Ensuring the integration of the FSMS requirements into the organization’s business processes. Implement a validation strategy based on current regulatory and pharmaceutical industry standard and expectations. Maintain Validation plans and ensuring the approach to validation is consistent. Maintenance of validation plan ensuring that all processes, equipment and services remains current to GMP and Global GAP standard and records are available to support audits. Coordinate and support on site Audits conducted by external Providers. Evaluate Audit Findings and implement appropriate corrective actions. Ensures QMS gaps and risks are identified and addressed. Update and initiate relevant SOP’s. Establish prerequisite programmes (PRPs) and Manage Documented information. Perform self-inspection to establish level of compliance. Handling of Non-Conformance, CAPA’s and Customer complaints. Handling Change management. Ensure compliance and implementation of relevant legislation. First to attain GAP Certification for Medical Grade Cannabis. Show less

    • South Africa
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Pharmacy Technician/ Head of production
      • Apr 2017 - Apr 2019

      Ensure total GMP compliance of the Production department to pharmaceutical cGMP and Food Safety standards and support production activities from a pharmaceutical and regulatory perspective. Identify and address daily pharmaceutical and process problems. Identification of process improvements opportunities in order to prevent product loss and unnecessary product discard. Liaises with the RP on production situations and collaborate with supporting departments on solutions. Ensure that the daily production programs and targets are met. Closely track daily line outputs by aligning with the production scheduling department on a daily basis. Ensure accurate completion and reconciliation of BMR’s. Reviewing and auditing thereof. Logging and closing deviations, CAPA’s and Customer complaints. Supervision and coordinate training initiatives to ensure that all production staff are properly trained and competent to perform their job function. Perform departmental internal audits to establish level of compliance Participate in External Audits and the completion of the subsequent audit finding report. Approval of all raw materials and packaging to commence manufacturing operations and dispensing thereof. Ensure accurate reconciling to balance stock levels of the facility and maintain financial control. Staff allocation and line loading assessments for optimal output of product. Maintain staff discipline in all production areas to ensure adherence to facility SOP’s and SOF’s. Show less

    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Production Pharmacy Technician
      • Feb 2016 - Apr 2017

      Manufacturing of sterile and non-sterile Medicine. Monitor preparations for the production process to ensure GMP compliance. Monitor and udjust production process to ensure compliance with product specification. Confirm clearance of raw and packaging materials. Oversee sampling of Raw materials and packaging materials Perform in process controls according to SOP. Assist with stability studies. Reconcile and Review BMRs Conduct internal inspections and participate in external inspection. Conduct product anomaly investigation Show less

Education

  • Nelson Mandela Metropolitan University
    Pharmacy Technician, Pharmacy, Pharmaceutical Sciences, and Administration
    2013 - 2015
  • Udemy
    Process Validation in ISO 9001/Quality /Risk Management
    2018 - 2018
  • Udemy
    QMS Auditor / Lead Auditor
    2018 - 2019

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