Head of Commercial Quality and Responsible Pharmacist - Randburg
R
90000
per month
Randburg, Gauteng
Randburg,
Gauteng
more than 14 days ago
13-02-2018 1:38:14 PM
02-03-2018 11:58:51 AM
We have a brilliant opportunity available for a Head of Commercial Quality and Responsible Pharmacist for a Multinational Pharmaceutical company, 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.
Required capabilities:
Solid experience in quality management
Strong knowledge of local and international acts/regulations/guidelines concerning GDP/GMP and Quality Assurance
Strong knowledge of the legal requirements of a Responsible Pharmacist
Previous experience as a Responsible Pharmacist will be an advantage.
Very good communication and inter-cultural skills
Interdisciplinary thinking and open communication
Excellent interpersonal skills, assertiveness, decision-making ability
Salary: R 60 000 - R 90 000, including benefits
Email Resume to: melanie at nrs dot co dot za
REF: Qualitypharm