Commercial Quality Specialist, Africa

3 weeks ago

Johannesburg, Gauteng, South Africa Abbott Full time

About the Role

This position works out of our Johannesburg location in the Abbott Rapid Diagnostics Division. In this division, we're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

Key Responsibilities

  • Ensure that product(s) and/or service(s) meet the established standards of quality including reliability, usability, and performance from a Distribution business standpoint.
  • Work closely with all staff members and promote Abbott's Quality Requirements.
  • Contribute and support towards the Quality Management system and aid in maintaining its effectiveness and efficiency for the Africa & Middle East region, and when required for EEMEA region.
  • Work towards ensuring Abbott Global Procedures are integrated into the local quality management system and ensure its implementation.
  • Perform & manage distributor assessment(s) and audit(s) as required.
  • When required, support the organization with conducting & managing supplier assessment(s) and audit(s).
  • Ensure the processes needed for the Quality Management System (QMS) are established, implemented and maintained.
  • Maintain the Quality System to ensure it meets the local quality management system and Abbott Quality System requirements.
  • Support departments in finding solutions to issues raised and escalate to the Quality Manager for support when required.
  • Assist with the set up and coordinate Quality meetings including Management Reviews, the distribution of minutes and follow through of actions for verification and closure.
  • Prepare the minutes of the MR meetings for review with the team and Quality Manager.
  • Support the review of the Quality Tracker on a monthly basis and advise outstanding items for closure to departments.
  • Ensure that all Quality Communication such as Product Hold are executed and all relevant documentation completed, approved, submitted, and filed to ensure no further distribution of product.
  • Identify any risks noted and capture in the Risk Register and escalate to the Quality Manager.
  • Ensure the Audit programs devised are adhered to and all audits are performed in accordance with said procedures.
  • Provide advice on disposition for Product Deviations receipted at selected Abbott 3rd party warehouse and logistics company.
  • Approve all destruction requests for nonconforming products.
  • Authorize product returns at selected 3rd party warehouse and logistics company, advise on disposition after inspection and investigation of product handling during storage and transportation.
  • Assist in ensuring that all the required Quality Assurance related training is performed, and records filed/retained.
  • Perform distributor/supplier Audits/ Pre-assessments for potential distributors identified by commercial within the EEMEA region in support of the distributor on-boarding process.
  • Perform distributor Audits/Assessment for already existing distributors in EEMEA region as required.
  • Report and track any potential Abbott product theft, diversion, counterfeit, and parallel importing for Africa and Middle East, and when required for EEMEA region.
  • Uphold the company's core values.
  • Responsible for management and satisfactory resolution of product issues in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
  • Responsible for management and satisfactory resolution of Quality Incidents (non-conformances) in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
  • Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.
  • Responsible for coordination and management of site Quality metric tracking, trending, and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.
  • This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial office lead.
  • Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards, and regulatory requirements.
  • Other duties as assigned.

Third Party Manufacturer Quality Role

  • Lead, Drive and Support Site Quality Remediation for Repackaging/Manufacturing In-Vitro Diagnostic products and establishing right systems.
  • Ensure the external manufacturing sites assess Quality systems effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate.
  • Support manufacturing sites in the investigation, evaluation, and implementation of actions to eliminate root causes of non-conformances.
  • Establish and monitor metrics for the measurement of Quality indicators to ensure effectiveness and value to the business.
  • Provide disposition for non-compliant products and assures escalation of potential quality or compliance problems to site quality leader.
  • Ensure effective risk management processes are implemented to prevent unanticipated failure modes.
  • Ensure quality processes are followed across the external network by enforcing Quality Agreements, establishing product specifications, and deploying quality assurance procedures meeting Abbott requirements. Ensure external partners remains compliant to health authority regulations and other country statutory requirements.
  • Ensure defect free and timely product supply to the market. Establish Governance strategies along with Operations, Planning, Regulatory Affairs, and supply chain colleagues, to ensure that external partners continue to remain compliant, agile and flexible to deliver quality products per business needs. Quality events and issues are resolved speedily and through cross functional collaboration as deemed necessary.

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