Specialist validation QA for QC

工作内容

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

QA Validation coordinator for GSK vaccines QC laboratory

In this role you will…

As QA Validation coordinator in QA for QC & R&D infrastructure & Equipment delivery team you will provide QA support to the QC and maintain the compliance level of this department with regulatory and GSK standards. You’ll be included in a team of 10 internal people and several external people.

The specific scope of the job is QA oversight of qualification/validation of QC - R&D equipment:

• Infrastructure equipment (as autoclaves, isolators...) and systems (as HVAC, clean utilities....)
• and LabEquipment including CSV qualification aspects (classical analytical equipment as HPLC,... and also new analytical technologies as Nexus, FACS...)
  

Through this job you’ll have the opportunity to see a lot of different technologies and to be involved in projects including infrastructure aspects and new technologies.

Your Responsibilities

• You represent QA (decision responsibility) in operational meetings related to the area of responsibility (staff meeting, projects follow-up meeting….)
• You provide QA expertise support to new infrastructure and/or New lab equipment’s installation projects related to his/her area of responsibility. You act as a real partner/stakeholder in those projects, not only as compliance authority.
• You write or review, challenge and approve the validation documents (VP/VSR, IQOQ, PQ, Risk assessments...including Periodic review documents) associated in accordance with procedure and timelines
• You review, challenge, and approve CAPA, change controls and SOPs related to the area of responsibility in accordance with procedure and timelines
• You support QC in the audit’s preparation, and present topics during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility
• You promote a continuous improvement mindset in day-to-day activities within his/her team and peers and in partnership with QC operational teams to ensure the compliance level is maintained in line with cGMP and GSK standard requirements.
• You participate with rest of the team to quality oversights on the shopfloor and internal audits in accordance with the QA oversights/L1 audit planning
• You ensure the critical topics are adequately and timely escaladed to higher management
  

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

Why you?

Qualifications & Skills

• Scientific university degree (Pharmacist, Engineer, or equivalent) or equivalent by experience
• Minimum 3 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
• Good Knowledge of English
• Quality mindset and good Knowledge of GMP regulated environment
• Good Knowledge of Validation processes
• Has already had the opportunity to work in "project mode"
  

Preferred Qualifications & Skills

• Very good team player and adaptability
• Good communication skills
• Working autonomously, must be capable of leading specific initiatives and collaborating hand to hand with operational teams
• Do not hesitate to go "on the field" to understand and find solutions
• Open-minded flexible and challenging
• 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.

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 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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