Manager QA, Filling

Conteúdo do emprego

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 modern employer, we empower you to be yourself, share ideas and work collaboratively

Manager QA, Filling

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.

In This Role You Will

• Takes the full Quality Assurance responsibility for one or multiple operational activities related to development, investigational vaccines manufactured, and GIO support in the QA IMPQ department.
• The responsibility covers Validation, Technical services and quality systems
• Ensures QA oversight of the GMP documentation
• Ensures all equipment’s and facilities are adequately calibrated, qualified and validated (regarding development phase)
• 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
• Ensures critical topics and risks are adequately managed and timely escalated to higher management
• Performs internal audits
• Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
• Understands and manages complex technical/production problems and evaluates their potential impact on product quality.
• Manages deviations and CAPA related to the area of responsibility. Generates possible solutions, assesses each using standard procedures and makes a sound decision.
  

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

Why you?

Qualifications & Skills

• Master of Sciences in Bioengineering, Biotechnology (or any other Scientific degree) or equivalent professional experience
• At least 3-4 years of experience in product manufacturing
• Solid experience in validation in Pharmaceutical environment is required considering the diversity of the analytical and manufacturing activities of clinical vaccines
• Fluent in French (written and spoken) and in English
• 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
  

GSKTechTalent

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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