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OpQSS – Customer Incident Mana...

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GSK

OpQSS – Customer Incident Management – QA Specialist

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Position Title: OpQSS – Customer Incident Management – QA Specialist


Working Location: Wavre


Employment Status: Full-Time Regular


Required Experience: Not Indicated


Required Education: Not Indicated


Travel Required: 0%


Job Description:

Job Purpose:


- Management of technical complaints for GSK vaccines worldwide (More than 120 markets) in a timely manner and define actions in order to prevent recurrence of complaints, major incidents and recalls from the market

- Perform data trending with rapid identification and analysis of recurrent technical issues, to define quality profiles of all products and drive patient risk management

- Participate to the Management of serious product incidents on vaccines, which may lead to product recalls and communications to authorities, by being the Secretary of the Product Incident Review Committee


Key Responsibilities:


- Ensure complaints are recorded, investigated adequately and answered in a timely manner for GSK vaccines worldwide (More than 120 markets).

- Analyze complaint trends and manage complaints in such a manner to prevent recurrence of complaints, major incidents and recalls from the market.

- Manage technical signals seen on certain batches in accordance with procedures in place

- Maintain continuous interactions with the Pharmacovigilance dept. in order to ensure appropriate investigation of safety signals and safety review of potential quality issues

- Contribute to the continuous improvement of the Complaints Management System

- Participate actively in taskforces related to Complaints

- Respond to external (GSK commercial units) and internal (Manufacturing sites, Safety, etc.) clients' needs through explanation and clarification of issues and reporting (per building, site, product, country, topic )

- Participate to the management of serious product incidents on vaccines, which may lead to product recalls and communications to authorities, by being the secretary of the Product Incident Review Committee; which is a cross-functional and multidisciplinary team involving representatives (Directors, VPs) from different departments as Quality Labs, Regulatory, Legal, Safety, Medical, and Communications which mission is to evaluate and decide if a batch must be recalled. Liaise with the GSK Corporate to ensure the Product Incident Management Process is respected.

- Coordinate vaccine recalls when needed

- Represents GSK Vaccines in case of inspection by Authorities to defend Technical Complaints and Recall systems; prepare inspection-ready documentation and more generally offer support in case of inspection


Our Offer:


At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.


The department:


Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.

Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.


Our Company:


GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.


GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.

For further information, please visit www.gsk.com


Essential Skills:

- Biological manufacturing processes knowledge is an asset

- Fluent English and French, spoken and written

- 2 years of industry experience, preferably within the Pharmaceutical Industry

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Résumé des fonctions

Reference Code:PCK343-330396
Job Status/Type: Full Time
Employee
Location: Wavre, Walloon-Brabant 1300

Informations de contact

GlaxoSmithKline

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