QA Validation Specialist Good Manufacturing Practices

Job content

Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer.We realize 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 modern employer, we empower you to be yourself, share ideas and work collaboratively.

About The Role

As part of the Quality for R&D department, our Investigational Medicinal Product Quality (IMPQ) team is composed of around 50 people from technician to director. We work in partnership with Analytical R&D (ARD) and Manufacturing and Clinical Supply (M&CS) to produce (from the cell bank) and release clinical vaccines to finally ship them to the patients.

We work with all kind of Vaccines, from old (e.g. Viral attenuated) to established technologies (e.g. CHO) via game changing ones (e.g. mRNA). Thus, this is a very changing environment requiring agility and pragmatism.

We would be delighted to welcome you.

Key Responsibilities

• Assure and maintain the quality of the product and processes validation (Standard procedures, Quality Reviews).
• Ensure that equipements, products and processes for Phase I - II and III are qualified and validated in accordance with GMP, local, corporate and international regulations.
• Strongly interact with colleagues in the IMPQ teams, the TRD M&CS department and the network to ensure delivery of vaccines.
• Challenge, review and approve qualification and validation (URS, IQ, OQ, PQ, VP, VSR, equivalence certificate, requalification protocol/report, design qualification and the data associated) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures.
• Write some validation (PR, Annual assessment) documentation according to GSK standards and procedures.
• Challenge existing ways of working aiming for continuous improvement and validation process efficiency.
• Schedule and coordinate validation routine activities with the head of IMPQ.
  

This job opportunity is a permanent contract based in Belgium, not open for relocation.

Why you?

Qualifications & Skills

• Strong Scientific background is required to understand the product manufacturing and better evaluate the risks to be mitigated by the qualification or validation exercise.
• Solid experience in validation in Pharmaceutical environment is required considering the diversity of the analytical and manufacturing activities of clinical vaccines.
• GMP mastery is a must have.
  

Preferred Qualifications & Skills

• Risk based approach methodology adept
• Easy collaborative &networking capabilities
• Good communication skills
• Agile mindset
• Li-GSK
  

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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

Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.

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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