Site Name: Belgium-Wavre
Posted Date: Mar 4 2025
QA Operations Senior Specialist (6-months mission)
Job purpose:
As QA Operations Senior Specialist in a dynamic team with different opportunities for personal development, you will provide QA support to the QC department; especially for stability and product coordinators.
You will maintain the compliance level of this department with regulatory and GSK standards, promote, master and ensure the quality systems and cGMPs are in place/in use and will be responsible for quality decisions regarding products and activities.
In this role, you will...
* Review, challenge and approve the SOPs and change controls related to the area of responsibility in accordance with procedure and timelines
* Provide QA approvals for reports and stability protocols / PQRs annexes
* Ensure QA oversight (e.g. Monitoring Management) within the QC department for diverse activities covered by the team (stability, material prep, sample management, master data, etc.)
* Provide QA Support for deviations/SOPs/CAPA/eCC related to QC partners activities (stability/Release/QC material preparation /Reception/ Master data, etc…)
* Support QC in the L2 to L4 audit’s preparation
* Promote a continuous improvement mindset in day-to-day activities within your team and peers and in partnership with QC to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
Why you?
Basic Qualifications :
* Scientific university degree (Pharmacist, Engineer, or equivalent) or equivalent by experience
* Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
* A previous experience in Quality Assurance, ideally related to sample management / stability studies environment
* Good knowledge of FDA/EU/ICH/CDN/AUS guidelines
* Experience in FDA/EU/WHO inspection
* Good communication skills
* Fluency in French, good command of English
Preferred Qualifications:
* Good manufacturing and laboratories process knowledge
* Working autonomously, must be capable of leading specific initiatives and collaborating with operational teams
* Good team player and adaptability
* Tech savvy
Application closing date: Sunday 16 March 2025
Please take a copy of the Job Description, as this will not be available post closure of the advert.
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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 organization 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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