Specialist QA Validation

il y a 1 semaine

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: May 24 2024
**_
Specialist QA validation _**

**Job Purpose**
- _ Built a strong partnership with the MU stakeholders in Validation/Process, Projects and external partners outside MU (central and global functions)_
- _ Ensure regulatory compliance and audit readiness of the MU in scope and defend the validation approaches and decisions during internal and external audits with Validation partners_

**In this role you will **
- _Be the dedicated quality partner for validation activities_
- _ Participate to the definition of the validation strategy for various projects_
- _ Review and Approve validation documentation (projects and routine) in a timely manner_
- _ Ensure adequate oversight of validation activities on the floor_
- _ Participate to and challenge investigations related to the validation activities _
- _Be an active participant of the process and technical improvements in the unit, and simplifications_
- _ Ensure timely escalation to Management of critical issues during validation, or impacting the validated status_
- _ Pro-actively identify potential quality and compliance risks and manage these risks through the quality systems and escalation process_
- _ Ensure QA representation and decision making in all meetings related to his/her area of responsibility_
- _ Acts as front-line spokesperson or QA representative during inspections/audits for validation activities_
- _ Ensure compliance with GSK Vaccines standards policies, procedures and local regulations_

**_ 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 (Biotechnology, Agronomy, Chemistry, Pharmacy or Engineer)
- At least 5 years professional experience in pharmaceutical environment, in quality and validation environment
- Good oral and written communication skills
- French is mandatory
- Good Knowledge of GMP Regulated environment related to validation activities.
- Good interpersonal relationship skills
- Problem solving and solution-oriented mindset

**Preferred Qualifications & Skills**:

- Agility to adapt to various projects/equipment/environments
- Good oral and written communication skills in English
- A knowledge of different regulations and standards related to validation activities
- To be a good team player in order to success in each validation project
- Able to take decision under pressure conditions
- Good knowledge of equipment processes
- Proactive and ready to take the lead to make things happen
- Ability to work under pressure on multiple deliverables within project time lines
- Li-GSK

GSKTechTalent

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 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.

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

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