Specialist QA Validation for primary operations

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Site Name: Belgium-Wavre
Posted Date: Apr 2 2021

Job Purpose

The purpose of the role is to assure and maintain the organization of the activities linked to the quality oversight of the validation activities in a building of bulk production. By the quality oversight of the process and the use of quality systems in place, ensure the quality of the equipment/process/product and the supply of the bulk product in a timely manner.

Your Responsibilities

• Represent Quality assurance in the decision linked to the activities
• Participate the improvement of the quality systems in the validation activities to ensure compliance of validation activities and the commercial production
• Ensure and organize the implementation of quality oversight activities linked to the documentation review
• Identify, Develop and Implement improvements to the quality oversight processes
• Training and coaching manufacturing and validation on efficient deviation management and risks identification, including facilitating and/or contributing to risk identification workshops or root cause analysis for deviations.
• Acts as a QMS subject matter expert and assure that current activities are in line with requirements
  
  

Why you?

Basic Qualifications

We are looking for professionals with the following required skills to achieve our goals (must-have):

• University degree: Master’s degree in sciences/Engineering e.g. Pharmacist / master’s in sciences / Bio Engineer pharmaceutical
• Minimum 5 years in the Pharmaceutical/Biotech industry with significant experience of GMP in maintenance and validation environment
• French fluent and professional writing and speaking in English are a must.
• Preferred knowledge of vaccines and/or immunology process and products (manufacturing).
• Preferred strong knowledge of validation activities
  
  

Preferred Qualifications

The following characteristics are assets (nice-to-have):

• Good interpersonal and communication skills
• Demonstrated ability of stakeholder management
• Demonstrated experience in influencing improvement activity to ensure implementation of appropriate actions
• Knowledge of primary processes is an asset
  

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

Vaccines Global Qualityis responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

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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