Quality Manager Commercial - Sandton Verfied

R 550000 per annum Sandton, Gauteng Sandton, Gauteng more than 14 days ago 07-04-2014 8:48:25 AM
05-05-2014 8:48:25 AM
Commercial Quality Manager
A Pharma / FMCG company in Bryanston needs to appoint a Commercial Quality Manager who will be reporting to the Regional Quality Manager.
Job Purpose:
The job exists within the commercial business units to ensure that the mandated Quality Management Systems requirements for commercial operating units are met. The job is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance.
Responsibilities
Quality Management:
1. Responsible for the QMS (Quality Management System) implementation and monitoring of compliance within the Local Marketing Company.
a.) Implement and maintain effective Quality Assurance systems to ensure that local technical operations are in full compliance with company standards and policies, GMP/ GDP and regulatory requirements by performing the following:
- Implement the QMS GQPs and GQGs required for Marketing Companies
- Ensure that all SOPs are in place, updated and training has been conducted
- Promote QMS management principles and seek continuous improvement of the processes
- Coordinate QMS Annual Management Reviews
b.) Develop, specify and approve systems that have an impact on the quality of imported, and, where relevant, contract manufactured, products in line with all relevant GQPs:
- Review and approve TTS (Technical Terms of Supply) and liaise with manufacturing sites to ensure compliance to local registered technical details
- Review, approve and closure of change controls
c.) Monitor and assess quality systems by means of audit and self-inspection, and other forms of evaluation against company standards, GQPs, GMP and regulatory requirements:
- Conduct self, cross functional audits
- Coordinate or conduct audits of warehouse and distributor, artwork studios, other non-manufacturing 3rd party contractors
- Review internal audit findings and ensure close-out of CAPAs (Corrective and Preventive Actions)
- Conducts risk assessment of systems and activities that are being carried out in the business to ensure that quality risk areas are managed
d.) Ensuring a quality assurance input into the main aspects of the local company operations that influence product quality
2. Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
3. Acts as the primary liaison with the GMS supplying sites, Supply Chain and Regional Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied.
4. Ensure that all colleagues in the commercial operating units are adequately trained on the procedures and processes that relate to QMS implementation and regulatory compliance.
Product Incidents/Customer Complaints:
1. Manage product incidents and support product recalls.
2. Report and follow-up on product complaints with manufacturing sites, customers and Commercial teams.
3. Conduct analysis of product complaint trends in conjunction with Medical Affairs.
Artwork Management:
1. Ensure a robust artwork process, aligned to GQP, GQMP and GQG, and with clearly defined roles and responsibilities, is in place and in use.
2. Monitor compliance and escalate non-compliance and risks.
Local Repacking:
1. Oversee all matters pertaining to regulatory and QA compliance for repacking procedures to ensure timely QA batch release of repacked orders before distribution and/or re-export:
- Liaise with distributor on repacking instructions, and monitor repacking processes
- Liaise with printer on the component artworks
- Proof check and QA release incoming stocks and components before repacking
- Ensure documentation of batch records and retention of samples
Distributor/Logistics Service Provider/Contractor Management:
1. Conduct audits of local Logistics Services Provider, Distribution warehouses and printers/artwork studios and ensures that the contractors comply with GSK and regulatory requirements.
2. Review, update and finalize all Distributor Quality Agreements at renewals

Education and Experience:
- Successful completion of relevant tertiary qualifications – Science Degree
- Minimum of 5-8 years’ experience within the Pharmaceutical/Consumer Healthcare/FMCG industries, preferably in the capacity of a senior quality specialist or a manager
- Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and audits
- Strong knowledge of regulatory requirements pertaining to GMP/GDP
- Good knowledge on effective quality documentation systems