Customer Incident Management – QA Specialist

il y a 1 mois

Wavre, Belgique 1849 GlaxoSmithKline Biologicals S.A. Temps plein

Ready to help shape the future of healthcare? Your talent can bring our science to life

As a , we empower you to be yourself, share ideas and work collaboratively.

Job purpose

Management of technical complaints for GSK vaccines worldwide in a timely manner according to SOPs 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 (PIRC)

In this role you will…

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 and PIRC Systems.

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 (PIRC) and recall coordinator if recall decided; which is a cross-functional and multidisciplinary team involving representatives (Directors, VPs) from different departments as Quality Labs, Regulatory, Legal, Safety, Medical, and Communications. The mission of the PIRC is to evaluate and decide if a batch must be recalled. Liaise with GSK Corporate to ensure the Product Incident Management Process is respected.

Coordinate vaccine recalls when needed

Represent 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

Why you?

University degree preferably in Sciences (Bio Engineer, Biologist, Chemist , pharmacist)

A broad experience preferably within the Pharmaceutical Industry (good understanding of GxP requirements)

Experience in Quality and/or Customer complaint management and product Incident management

Fluent English and French, spoken and written

Flexibility and ability to work under pressure and/or with strict deadlines

Analytical mindset and capacity to challenge the status quo

Ability to engage people from different areas of expertise.

Ability to communicate complex information both orally and in writing. 

Work effectively in a highly matrixed organization across geographies and cultures.

Capacity to work in a regulated environment of pharma / biopharma / vaccines industry.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.


 
Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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