QA Specialist IMPQ (Investigational Medicinal Product Quality)

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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

QA Specialist IMPQ (Investigational Medicinal Product Quality) - QA ARD

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.

You have an experience as a QA analytics in the pharmaceutical field? You are searching for a new opportunity and you are interested by being part of all the steps of candidates vaccines production? We would be delighted to welcome you!

In This Role You Will Work On

Quality management

• Organize and take the full Quality Assurance responsibility for operational activities related to development, investigational vaccines manufactured, and GIO support. The quality assurance responsibility covers the analytical part.
• Ensure timely escalation to Management according to procedure in place (included major deviations/issues, quality council process)
• IMPQ projects coordination in and outside CM&S
• Organize and take the Quality Assurance responsibility for new projects in ARD.
• Drive a continuous Quality and Compliance improvement mind-set within the Operations environment to ensure compliance with cGMP’s and GSK Quality Management System and through good level of risk management.
• Provide analytics part necessary to release of Clinical manufacturing batches and other batches needed to assure New product development and launches in compliance with Good Manufacturing Practices and regulatory requirements
• Ensure regulatory inspection readiness, provide QA expertise and act as the key spokesperson during external Regulatory inspection
• Ensures QA oversight of the GMP documentation
• Ensures QA oversight for deviations, complaints, change controls, OOS investigation, CAPA in his field of activities. Ensures there are reviewed and handled in a timely manner
• Ensure all equipment’s, QC method and processes are adequately calibrated, qualified and validated (regarding development phase)
  

Safety / Quality

• Puts in place the necessary actions to ensure the safety of staff
• Identifies improvements in terms of EHS
• Respects and ensures the wearing of personal protective equipment (EPI)
  

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

Why you?

Qualifications & Skills

• Master of Sciences in Analytics, Bioengineering, Biotechnology (or any other Scientific degree) or equivalent professional experience
• At least 3-4 years of experience in pharmaceutical industry
• Fluent in French and English (written and spoken)
  

Preferred Qualifications & Skills

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

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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