Eac Quality Specialist - Johannesburg, South Africa - Abbott Laboratories

Abbott Laboratories
Abbott Laboratories
Verified Company
Johannesburg, South Africa

1 week ago

Thabo Mthembu

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Thabo Mthembu

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Description
Responsible for administering the affiliate Quality Management System, for the English Africa Cluster, with regard to:

  • Quality Document Management System,
  • Training related to the Quality System and GMP
  • Management of Audits at the affiliate
  • Coordination of Quality KPIs to Regional CDQA
  • Management of Approved Supplier List
  • Product Complaints, Counterfeits, Diversions, Tampering & Theft.
  • Change Requests
  • Exceptions, Planned Deviations & CAPA
  • Annual Product Quality Review
Ensures that all Quality Systems and Processes at the affiliate are compliant with local regulations and Abbott Quality policies and standards

Assists the Head Commercial Distribution Quality Assurance with Quality Management Review coordination and Agency Inspections/ External Audits


CORE JOB RESPONSIBILITIES

Quality Document Management System:

  • Maintains the affiliate Quality Document Management System & Quality Manual.
  • Controls local Quality Policies and documents (QD), ensuring compliance with local regulatory requirements and cGMP.
  • Coordinates communication, distribution, review and implementation of local Quality Policies and documents.
  • Maintains the QD database & revision schedule.

Training related to the Quality System and GMP:

  • Manages GMP & QD System training for new employees
  • Maintains an annual / biennial training program, as required, for existing employees.
  • Maintains QD training matrices and training records.
  • Manages monthly reconciliation of employees and maintains the company Organogram

Audits Management:

  • Maintains the affiliate Audit schedule and coordinates the audit program
  • Conducts audits of Third Party Vendors and printers as per the audit program
  • Participates in Audits of Distributors, Third party Manufacturers (TPMs) and Third-Party Labs (TPLs)as per the audit program
  • Coordinates and conducts internal audits of the affiliate's quality systems as per the audit program
  • Assists Head CDQA QA during Agency Inspections and Supplier audits
Quality KPIs

  • Coordinates the reporting of monthly Quality Metrics for the Affiliates to Regional CDQA

Approved Supplier List Management:

  • Maintains an Approved Suppliers List for Third Party Vendors and printers, Distributors, TPMs and TPLs, in compliance with the One Abbott Supplier Management requirements.
  • Maintains the Affiliate Customer list and Bone Fides of Distributors
Product Complaints, Counterfeits, Diversions, Tampering & Theft.

  • Manages the product quality complaint system.
  • Investigates all product qualityrelated complaints via the appropriate quality complaint handling system, and when necessary, ensures CAPA is put in place.
  • Ensure Counterfeits, Diversions, Tampering & Theft are logged in the complaints system and investigated
Change Request

  • Initiates Change Requests
  • Assists Head CDQA, EAC to Liaise with action item holders for completion of outstanding actions.
  • Assists to closes out Change Request and provides metrics for Management Review
Exceptions, Planned Deviations & CAPA

  • Register Exceptions & Planned Deviations processes.
  • Investigate exceptions and planned deviations and ensure CAPA is put in place.
  • Track CAPAs until closure.
Annual Product Quality Review

  • Maintains the Annual Product Quality Review (PQR) Schedule in alignment with the manufacturing site PQR publication dates
  • Manages the local Product Quality Review for all registered products in the English Africa Cluster

MINIMUM SKILLS REQUIRED

  • Detailoriented
  • Good organizational skills
  • Literacy in Microsoft Office 365, incorporating Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project and Microsoft Outlook
  • Communication and Presentation skills
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