Specialist QA Ops
il y a 4 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: Jun 30 2023
**_ Specialist QA Ops _**:
**Job purpose**:
As a QA Operational Specialist, you master the key quality assurance activities related to production and validation, project activities in your area of responsibility.
You will support the MPU Filling which main activities are the filling of a broad range of vaccines in syringe and vial presentations. Syringe presentations are filled on the S4 and S5 filling line. Vial presentations are filled on the TL1 liquid filling line and on the TL2 freeze dryer line.
**In this role you will **
- Ensure batches of the intermediate product related to the area of responsibility are released in a timely manner
- Ensure deviations, change controls and CAPA are reviewed and handled in a timely manner
- Represent QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, eCC, project) follow-up meetings,
- Ensure critical topics are adequately escalated to higher management
- Lead local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
- Understand technical/production complex problems and evaluate 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
**_ Why you? _**
- Qualifications & Skills:_
- University degree level in a science (Engineering, Chemistry, Biochemistry, Biotechnologies...) or equivalent by experience
- A broad previous professional experience in Quality Assurance, Production, QC in industrial environment related to bio / pharmaceutical products / medical devices
- Preferred Qualifications & Skills:_
- Quality mindset
- Good communication skills (applicable to French and English)
- Broad knowledge in Quality Assurance systems: deviations, CAPA management, change control
- Good knowledge of GMP regulated environment
- Good team player and problem solver
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 positively impact the health of 2.5 billion people by the end of 2030.
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
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