Specialist QA Validation - Technical Service

Job purpose:

The QA TS/Validation department is responsible for ensuring overall quality standards are met for products. Responsible for programmes to establish and maintain quality standards of existing products and services, as well as developing programmes to focus employees on quality improvement. Approval of batch release to the market
Develops and implements programs to establish and maintain quality standards of existing products, and internal systems and processes. Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.

Your responsibilities:

The responsibilities of the QA TS/Validation Specialist are among others:

• Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV,TCD) documentation in line with projects and ensure they are written in accordance with the GSK Vaccines standards and procedures.
• Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK Bio standards and procedures.
• Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
• Support from a compliance point of view the MPU Product&Process, PMO team, Technical Services, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
• Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations.
• Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up.
• Participate to external audit as appropriate.
• Implement change initiatives involving processes, technologies and people which contribute to the overall effective improvement of Quality within the MPU.
• Apply lean sigma across the teams to ensure continuous improvement.
• Share and integrate best practices within the Vaccines Quality Network.

Why you?

Basic Qualifications:

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

• Engineer or university degree in biotechnology, agronomy, chemistry, pharmacy, etc.
  Knowledge
• Good adaptability to a new complex environment with multiple interfaces
• Knowledge of GMP & aseptic environments
• Global vision capability project quality, risk based quality
• Analytical and anticipatory capacity
• Good oral and written communication skills
• Focused on values of quality, integrity, trust and discretion
• Knowledge in technologies, Closed system, production equipment’s, Utilities & Facilities
  Solution-oriented, proposal-driven and negotiating skills, critical thinking
• French speaking mandatory, ability to read and speak English preferred

Preferred Qualifications:

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

• Minimum 5 years experience in an aseptic/laboratory environment, industry, quality, production
• Experience in a regulated environment such as cGMP
  Industry validation experience
• Knowledge of attenuated viral processes is a plus
• Advanced knowledge of aseptic, closed systems, utilities & facilities technologies
• Experience as a QA Validation

• 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.

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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