Specialist QA Computer System Validation (CDI)

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Site Name: Belgium-Wavre
Posted Date: Jul 26 2021

Job Purpose

The QA BEEM department ensure the quality oversight of the Technical/Engineering Operations on Belgium site, the Capex Projects, the Automation/CSV operations and the Validation group. This group is the Quality partner for the Belgium Engineering and Asset Management organization while ensuring the implementation of quality strategies and programs to support the business regarding applicable regulatory, quality, safety and ethical requirements as defined by GSK Vaccines internal policies and procedures and respective national and international regulations and laws

Your Responsibilities

Ensuring oversight QA on (the validation of) automated and computerised systems used across commercial and industrialisation operations at Belgian sites (Rixensart, Wavre, Gembloux).

Responsibilities

This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following

• Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerised systems
• Writing, reviewing and approving of Validation Plans (VP)
• Writing, reviewing and approving of Validation Summary Reports (VSR)
• Reviewing and approving of design documentation (TCD, ERES, URS, DQ, ...)
• Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
• Writing and reviewing of Periodic Review Reports (PR)
• Reviewing and approving of CSV specific documentation (inventory, ...)
• Ensure QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerised systems.
• Manages the workload related to his area of responsibility (project, MPU, automation team, cluster, ...) as required by site priorities.
• Support team and management during internal and external audits
  
  

Why you?

Basic Qualifications

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

• Bachelor’s degree with experience in the field, preferably in Automation, Engineering, Sciences
• Minimum 3 years’ experience in a computer systems validation role in a pharmaceutical environment.
• Fluent in French & English
  
  

Preferred Qualifications

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

• CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
• Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)*
• Autonomy
• Team player
• Problem solving skills

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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.

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.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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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