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Quality Manager (FWCA) At GlaxoSmithKline Plc.

Date Posted: 04/Oct/2013
Deadline: Not Specified


Job Purpose/Scope

The successful candidates’ principal purpose is 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.


Key Responsibilities

Responsible for the QMS (Quality Management System) implementation and monitoring of compliance within the Local Marketing Company:
• Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
• Acts as the primary liaison with the GMS supplying sites, R & D and Regional Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied
• 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
• Manage product incidents and support product recalls.
• Report and follow-up on product complaints with manufacturing sites, customers and Commercial teams.
• Conduct analysis of product complaint trends in conjunction with Medical Affairs
• Oversee the effective implementation of Artwork Management procedures within the commercial teams
• Plan and co-ordinate pack changes, online artwork creation and proof-reading.
• Ensure that the commercial business units can effectively use the global pack management systems (GPM) for Artwork
• 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:
• Conduct audits of local Logistics Services Provider, Distribution warehouses and printers/ artwork studios and ensures that the contractors comply with GSK and regulatory requirements.


Qualifications, Experience

The successful candidate will have a minimum of a Bachelor of Science degree. The candidate will have a minimum of 5-8 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager.


The candidate will have good knowledge on effective quality documentation systems, Strong understanding of and experience in quality assurance systems and Strong knowledge of regulatory requirements pertaining to GMP/GDP

The skills for the role include but are not limited to: professional written and verbal communication skills, Analytical mind and good problem solving skills, team work and people management skills, good time management skills, ability to multi-task and work under pressure. Ability to read, write and speak French will be advantageous.

Method of Application

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