Specialist QA Release, Trending

il y a 4 jours


Wavre, Belgique GSK Temps plein

**Specialist QA Release, Trending & Compliance (RTC)**:
Ready to help shape the future of healthcare? Your talent can bring our science to life

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

**In this role you will **
- Drives and leads the release process for the Formulation and filling on Wavre site (WN16) in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements
- Drive the inspection readiness agenda to prepare internal audits or cGMP inspections, in a unit registered in the US, China, EU, Japan etc.
- Represent QA (decision responsibility) in all meetings related to the area of responsibility (deviation, CAPA, eCC )
- Act as a Subject Matter Expert (SME): (= knowledgeable of the QMS standard related to the area of expertise, ensures all requirements of the standards are cascaded in SOP’s, Accountable for gap analysis and related action plans)
- Drive quality governances within the unit (Quality Council, escalation etc.)
- be a key spokesperson during regulatory inspection
- Lead transversal projects and process improvements

**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**

**_ Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade._**

**_ Why you? _**

Qualifications & Skills:

- University degree in sciences: Pharmacist, Bio Engineer, Biologist, Chemist
- At least 5 years professional experience from which at least 3 years in a GMP Environment related to pharmaceutical production with preference to aseptic
- Good knowledge of cGMP
- Fluent in spoken and written English and French

**_ Why GSK?_***

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

**GSK Vaccines** - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

**Our department**:
**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.
- Li-GSK

vaccinessupplychain

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.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

**Important notice to Employment businesses/ Agencies


  • Coordinator Qc Release

    il y a 4 jours


    Wavre, Belgique GSK Temps plein

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