Specialist QA Validation & CSV
GSK
Wavre, Walloon Brabant, Belgium
5 dagen geleden

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    Specialist QA Validation & CSV

    CAROUSEL PARAGRAPH

  • Wavre, Belgium
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    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. These are 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 Trust priorities.

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

    Specialist QA Validation & CSV

    Are you looking for a QA validation role in the challenging Manufacturing & Logistics environment? Would you like to join a team of 6 persons doing the validation & technical services for Packaging & Warehouse activities?

    If so, this opportunity could be the perfect fit for your career!

    Ensuring and supporting oversight & QA activities on (the validation of) automated and computerised systems used across Packaging & Warehouse (MPU PWI) operations at Wavre.

    Together, within a dynamic team of 6 colleagues, as the quality interface, you support the Product & Process team with projects linked to the Packaging and Warehouse.

    Specifically, you ensure the local QA CSV activities in order to increase the service level.

    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 :
  • 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, SRA, 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.
  • You manage the workload related to his area of responsibility (project, MPU, automation team, cluster, ...) as required by MPU priorities.
  • You support the team and management during internal and external audits
  • This job opportunity is a permanent contract, based in Belgium.

    Why you?

    Qualifications & Skills :

  • Minimum Bachelor’s degree with relevant experience in the field or Master's degree, specialization in Automation, Engineering Sciences
  • Minimum 3 years’ experience in validation
  • Knowledge in computer systems validation role in a pharmaceutical environment.
  • Specific Knowledge required :
  • 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, )
  • Deep understanding of validation principles within GSK
  • Fluent in French & English
  • Preferred Qualifications & Skills :

  • Critical mind
  • Problem solving mindset and ability to work in partnership with your team and stakeholder
  • Ability to make independent decisions even under pressure, ability to adapt, work under uncertainty and accommodate flexible work demands.
  • Strong interpersonal skills with demonstrated ability to engage, empower and influence people
  • Ability to communicate complex information both orally and in writing.
  • Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution.
  • In depth understanding of cGMPs and regulations applicable to the Vaccine
  • GSKTechTalent

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