Specialist QA Operational - Rota
GSK
Wavre, Walloon Brabant, Belgium
2 dagen geleden

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    Specialist QA Operational - Rota

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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 Operational - Rota

    An operational role responsible for the QA oversight of operations in his / her areas of responsibilities.

  • Promote, master and ensure quality systems and cGMPs are in place in use
  • Responsible of quality decision regarding products / activities
  • Manage a team of Technician (not mandatory)
  • In this role you will

  • Implement and drive the application of the GSK Vaccines Strategy in his area responsibility and outside and is the representative of QA in multidisciplinary teams
  • Ensure the compliance on EHS topics in / outside his area and develop the EHS mindset within his team and peers
  • Ensure Quality Systems (deviation, OOS investigation, CAPA, documentation, training, change
  • control, validation activities, maintenance and calibration activities) are in place in use and handled in a timely manner

  • Ensure with his / her team that release of Product Batch Record and / or QC Release Documentation is under control in his area responsibility
  • Ensure compliance of the operations with cGMP, Authorities and QMS requirements and escalate major quality issues and / or compliance gaps to management and relevant governing bodies
  • Proactively informed and involved with the requirements needed with improvements of current processes to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
  • Act as QMS Subject Matter Expert (SME) and / or Single Point Of Contact (SPOC) on Quality Systems (knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are in place within department, accountable for gap analysis and related action plans, active member of SME / SPOC communities of practices)
  • Is the front line spokesperson during internal and external inspections (L2 / L3 / L4) for the subject of expertise as well as for all operational and technical aspects belonging to the area of responsibility
  • Ensure the respect of L1 and L2 audit planning and report closed in a timely manner, potentially realize L1 and L2 audit
  • Supervise / Manage day to day QA activities (Operations, Technical Services, QC, Warehouse,
  • Technical Services Support, Site Management) in an operational environment including multiple technologies and in his / her area of responsibility and ensure the relevant QA Oversight is in place (not mandatory if no team to manage)

  • Supervise a team in keeping with operations needs and team capacities and capabilities, responsible to reallocate activities in the team if needed (not mandatory if no team to manage)
  • Manage team performances through regular shopfloor presence, define action plans, ensure the implementation and measure through KPIs within his areas of responsibility (not mandatory in no team to manage)
  • Evaluate skills and performances, defines and ensures regular follow-up of development plans of each team member (not mandatory if no team to manage)
  • Manage complex technical and / or production problems, evaluate potential impact on product quality and escalate to management
  • Promote continuous improvement mindset in a day to day activities within his / her team and peers
  • Use Operational Excellence tools (e.g. : STP / IPO / PSS / Fishbone / 5S ) on day to day activities
  • This job opportunity is a permanent contract not opened for relocation.

    Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade.

    Why you?

    Qualifications & Skills :

    Pharmacist, Engineer or equivalent with at least 5 years with relevant experience

    Preferred Qualifications & Skills :

  • demonstrated high level of quality systems knowledge;
  • demonstrated analytical skills,

    prioritization management, well organized,

    listening and communication skills.

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