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Executive Job Listing


Head of Commercial Quality and Responsible Pharmacist

Industry: Other

Date posted: Tue, 13 Feb 2018


Location: Randburg,

Expires: Sat, 14 Apr 2018


Compensation: R60000 - R90000

Reference Number: qualitypharm



Job Description

We have a brilliant opportunity available for a Head of Commercial Quality and Responsible Pharmacist for our Multinational Pharmaceutical Powerhouse, Randburg

Purpose of the job

Head of the Commercial Quality function and Responsible Pharmacist in South Africa ensuring implementation of a standardized Quality Management System in HP and AH business units with the following accountabilities and compliance with all relevant Acts and Regulations:

  • Fulfil the function of Responsible Pharmacist
  • Owner of the Quality Management System
  • GDP responsible towards the authorities
  • Local Pharmaceutical Complaint Officer (LPCO)
  • System Officer for Launch and Change Implementation (SOLCI)
  • Product supply support
  • Management of External Service Providers
  • Provide support and oversight to the AH business unit Quality Manager
  • Head of Commercial Quality will delegate any of the above tasks to the direct reports as appropriate while keeping the final accountability.

 

Accountabilities:

Quality Management System Oversight

  • Establish and maintain the Quality Management System in South Africa.
  • Align with the key functions for the continuous improvement of South Africa QMS.
  • Lead the Quality Management Reviews (QMR) in South Africa
  • Ensure adequate CAPA plans are established and tracked for completion.
  • Ensure that initial and continuous training programs are implemented and maintained.
  • SOLCI responsibility including required text reviews
  • Annual Product Quality Reviews (PQR)

 

Good Distribution Practice (GDP) towards authorities

  • Manage audits by Corporate or inspections by local Authorities in respect to GMP/GDP.
  • Ensure that suppliers and customers are approved.
  • Approve any subcontracted activities which may have an impact on GMP / GDP.
  • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.

 

Local Pharmaceutical Complaint Officer

  • Coordinate and promptly perform any recall operations for medicinal products in collaboration with local Health Authorities.
  • Owner of the LAC (Local Advisory Committee) ensuring proper escalation of major and critical Product/Quality Defects.
  • Ensure that relevant customer complaints are handled effectively on timely manner.

 

Management of External Service Providers

Manage external service providers in all quality relevant aspects during the life cycle of a contract beginning with the issuance until termination to ensure regional/ local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines

  • re-packagers – secondary packaging distributors
  • freight forwarders
  • warehouses
  • distributors
  • graphic offices
  • contract laboratories
  • Co-promotion / Co-Marketing partners
  • Out-licensing partners
  • Outsourced services with GMP/GDP relevance

Provide support and oversight to the AH business unit Quality Manager

  • Will act as the Functional Manager of the  AH Quality Assurance Manager
  • Ensure Standard Quality Management System is created, Implemented and Maintained in both HP and AH Business units.
  • Act as escalation point for the AH Quality Assurance Manager.
  • Ensure KPIs reporting of AH Commercial Quality activities and act in case of trends and issues.

 

Other regulatory and/ or organisational requirements *

Must be a registered Pharmacist with the South African Pharmacy Council.

 

Direct Report is:

  • Quality Associate – South Africa
  • Functional Manager of the Commercial Quality Manager AH.

 

Interfaces (e.g. with other functions or business units) *

External:

  • GxP service providers (Distributors, agents and warehouses)
  • Local Health Authorities

 

Internal:

  • Corp. QA / Corp. QCO
  • Global Quality Services/SNQM
  • Global Quality & Compliance AH
  • 3PQM or SBS (if applicable)
  • Local functions e.g. local Quality function, Compliance Manager (Legal, Medical, EHS), LPCO, RA, Logistics, Legal.


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