Supervisor Qc

il y a 4 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: Apr 3 2024

**Supervisor QC V Biochimie**

**In this role you will **
- Ensure that methods are fully validated in a coherent and harmonized way
- Review analytical method protocols and assist analytical experts in the redaction of analytical validation report, work with statisticians to interpret all data generated. Approves analytical validation protocol and report.
- Ensures that periodic revision of revalidation assessment is performed and validation complements are added if required
- Ensure each validation parameter has been covered in a scientifically sound manner

Drive the AMV project on all commercialized vaccines/raw material, as to ensure that methods are fully validated taking into account that:

- Critical analysis is performed on the method parameters
- Analytical Method robustness is guaranteed, as well as stability indicating demonstration when required
- Validation pre-established acceptance criteria are scientifically sound and can be justified
- Analytical validation documentation is complete
- Periodic revision of validations is performed and validation complements are added if required
- Defend the validations during Inspections (PAI, GMP) and Audits, as well as in the responses to the questions addressed

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

**_ Why you? _**

Qualifications & Skills:

- Master’s degree of Science in physico-chemistry
- Expertise in Biochemistry
- Global knowledge on validations activities and requirements.
- Global knowledge of statistics applied to validation activities
- Critical analysis of data, global and pragmatic approach, problem solving oriented
- Technically knowledgeable in the areas Good Manufacturing Practices (GMP) and Compliance.
- People management and social skills to foster teamwork and to coach collaborators
- Good knowledge of written and oral English
- Good technical writing skills

Preferred Qualifications & Skills:

- Demonstrated problem solving and decision-making capabilities
- Strong communication and influencing skills
- Ability to prioritize, manage workload, and escalate issues
- Proactively manage personal development (knowledge and skills)
- Successful team leadership experience

Li-GSK

GSKTechTalent

**_ Why GSK ?_***

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 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.

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