Specialist QA Csv
il y a 1 semaine
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
**_
Specialist QA CSV & Automation_**:
Job purpose:
- Ensure oversight QA on (the validation of) automated and computerized systems used across commercial and industrialization operations at Belgian sites (Rixensart, Wavre, Gembloux).
**In this role you will **
- Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems:
- Writing, reviewing and approving of Validation Plans (VP)
- Writing, reviewing and approving of Validation Summary Reports (VSR)
- Reviewing and approving of design documentation (TCD, ERES, URS, DQ,...)
- Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
- Writing and reviewing of Periodic Review Reports (PR)
- Reviewing and approving of CSV specific documentation (inventory,...)
- Ensure QA activities on quality systems (CAPA, Deviation, Change Control,...) related to automated and computerized systems.
- Manage the workload related to his area of responsibility (project, MPU, automation team, cluster,...) as required by site priorities.
- Support team and management during internal and external audits
**_
Why you? _**
- Qualifications & Skills:_
- University (Master) degree or equivalent by experience in Automation Engineering Sciences
- Minimum 3 years’ experience in a computer systems validation role in a pharmaceutical environment.
- Good understanding of cGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11,)
- Experience with Validation practices and guidelines (life cycle approach, ICH, ASTM E2500,)
- Fluent in French & English
- Preferred Qualifications & Skills:_
- Autonomy
- Critical mind
- Team player
- Problem solving skills
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 Us?**
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. 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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