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Specialist QA CSV & Automation

Job purpose:

As a Specialist QA CSV & Automation, you will ensure the oversight QA on (the validation of) automated and computerized systems used across commercial and industrialization operations at Belgian sites (Rixensart, Wavre, Gembloux).

In this role you will…

• 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:

  o Writing, reviewing and approving of Validation Plans (VP)

  o Writing, reviewing and approving of Validation Summary Reports (VSR)

  o Reviewing and approving of design documentation (TCD, ERES, URS, DQ, ...)

  o Reviewing and approving of qualification protocols and reports (IQOQ & PQ)

  o Writing and reviewing of Periodic Review Reports (PR)

  o Reviewing and approving of CSV specific documentation (inventory, ...)

• Ensure QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerised systems.

• Manage 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

• Act as a Recognized expert (Local SME) for Computer System Validation (CSV) and Automation: be the referent person for the site

• Work on the alignment at team level regarding current Regulatory requirements and updates.

• Review and participate in the improvement of (local and vaccines) SOPs, templates, Global Standards,

  o Technical standards, ... to enhance compliance, standardisation and simplification

Why you?

Qualifications & Skills:

• Bachelor’s degree with experience in the field or Master degree in Automation, Engineering or Sciences

• Broad experience in a computer systems validation role in a pharmaceutical environment.

• 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, …)

• Fluency in English & French

• Good communication & stakeholder management capabilities

• Ability to work in autonomy as well as being a good team player

• Critical mind and problem solving skills

Application closing date: Thursday 31 October 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert.

#LI-Hybrid

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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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