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QA Specialist

Il y a 3 mois

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

In this role you will…

Master the key QA activities related to production, QC, maintenance and calibration, warehouse, CSV, validation, project activities in his/her area of responsibility

Ensure batches of the intermediate product related to the area of responsibility are released in a timely manner

Ensure deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner

Supervise a team of technicians, distributes their work and is responsible for their training and development plan • Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC Page 2 / 5 follow-up meetings, ICG project, …)

Ensure critical topics are adequately escalated to higher management

Act as QMS subject matter expert (SME) (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans)

Be the preferred front line spokesperson during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility

Lead local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements • Performs internal and act as external supplier audits

Understand technical/production complex problems and evaluates potential impact on product quality

Assess quality review files and draws adequate conclusions

Provide QA expertise support to new product introduction projects and related validations

Qualifications & Skills:

University Scientific background (Pharmacist, PhD in Life Sciences, Bio Engineer, etc.)

Minimum 2-3 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent

Fluent in French and good Knowledge of English (written and spoken)

High quality mindset and good Knowledge of GMP regulated environment

Preferred Qualifications & Skills:

Very good team player and adaptability

Very good communication skills

Working autonomously, must be capable of leading specific initiatives and collaborating hand to hand with operational teams applying quality fit-for-purpose

Open-minded: wants to extend her/his technical competencies and do not hesitate to go "on the field" to understand and find solutions

Flexible and challenging

#Li-GSK

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.


 
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