Specialist QA Subject Matter Expert Validation BeEM

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Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer.We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. Theseare at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal.You commit to living our values and expectations and performing against our Innovation, Performance and Trustpriorities. In return, GSK commits to providing the right environment for you to thrive.Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a , we empower you to be yourself, share ideas and work collaboratively

Senior Specialist QA Subject Matter Expert Validation BeEM

Ready to start 2022 with a new challenge? Do you want to join a transversal team in a stimulating and innovative environment? Do you have a quality mindset and a desire to learn?

This position is for you!

This position will allow you to be part of the QA Validation BeEM team in the SPU BeEM.

BeEM is a transversal team in Belgium and for support of all Belgian MPU’s. Specifically, QA team support all Subject Matter Expert in Technology and validation.

The team is composed of 5 people whose objective is to ensure that quality requirements, related to validation and technical expertise, are in place/in use for all Belgian validation activities in collaboration with Subject Matter Experts.

In this role you will…

• Ensure quality oversight of SME Technologies and validation from BeEM on various subjects
• Ensure quality oversight validation in SPU like LMSAT and Incoming Material (e.g transversal project like SUS, new raw material across MPU...)
• Contribute to inspection readiness for Technologies and validation for Belgium sites
• Embed quality culture and continuous improvement in SOPs, validation strategy and technologies
• Accountable for the technical support and knowledge to MPU/SPU’s to guarantee manufacturing and quality validation/technical are designed and executed to deliver expected product quality, as well as robust, sustainable operations.
• Be the compliance Authority of SOP, transversal CAPA / transversal risk & issues, involvement in deviation and voice of the site regarding technical and validation SME.
• Support SME during audit and inspection for various SME subject. (technical, engineering, validation subject)
• Ensure implementation of validation systems/Technical systems related commitments towards internal/external inspections
• Coach QA VAL from MPU during audit and inspection on validation subjects.
• Perform QA oversight for projects of limited or moderate scope and impact on the site.
• Improve & align his/her expertise to current GMP requirement included new technologies.
• Actively search for update in QRI and QMS linked to his/her scope
  

As support employee you ensure working in your department remains safe at all time. We expect that you:

• Understand, manage & assess all risks related to your activities. Ensure suitable & sufficient preventive measures are implemented and that you have necessary skills and medical aptitudes .
• Have the leadership necessary to manage all aspects related to PTW, LOTO process and Risk analysis procedure.
• Take part in AE investigation, CAPAs identification & implementation, with necessary diligence.
• Report of any unsafe condition and behavior through reporting system (HazId) and take immediate action where possible to rectify the situation. 5.Protectthe health and safety of yourself and others.
  

This job opportunity is a permanent contract not opened for relocation.

Why you?

Qualifications & Skills

• Master degree: Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline.
• Very good knowledge of French and English.
• 3-5 years in Pharmaceutical industry, with specific experience in a quality and/or validation role and knowledge of quality systems and vaccines regulations.
• Engineering in pharmaceutical environment or technological area is a plus
  

Preferred Qualifications & Skills

• QA in regulated environment
• Interaction with multidisciplinary engineer and multi MPU’s
• Good communication skills to influence and support Belgian site on complex subject
• Li-GSK
  

GSKTechTalent

Why GSK?:

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our Department

The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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