Specialist QA Validation Technical Service New HAV

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We will be delighted to hear from talented individuals that align to our values. Theseare at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

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Specialist QA Validation Technical Service New HAV

Attached to the dynamic QA TS-VAL team service of the NEW HAV building, composed of 6 people whose objective is to ensure the quality requirements, in connection with the validation and maintenance, for the hepatitis A vaccine

Your main role is to ensure that projects meet cGMP requirements and that validations in place remain aligned with these same requirements

In fact, the QA Primary Validation Specialist is part of the QA Operations for one MPU. You ensure the QA oversight of the continuous validation activities for one or several vaccine bulk production units.

You take up the challenges induced by the implementation of new procedures, processes, equipments ...

In this role you will…

• Challenge, review and approve qualification and validation (TCD, URS, IQ, OQ, PQ, PV) 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 team, Project 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

As a QA Primary Validation Specialist, you must be able to:

• Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
• Use a risk-based approach for problem solving and prioritization of tasks
• Blow a quality and compliance mindset through the validation activities
• Develop and continuously improve expertise linked to the primary validation activities as expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions
• Be a strong advocate for validation approaches and activities during internal and external audits
• Understands technical/production complex problems and evaluates potential impact on product quality

This job opportunity is a permanent contractnotopened for relocation.

• Why you?
• Qualifications & Skills:

• University degree in Sciences / Biological Engineering (e.g. Pharmacist / master’s in sciences / Bio Engineer)
• French speaker with good level of written and spoken English
• Strong knowledge of cGMP and guidelines (FDA/EU/WHO)
• Good knowledge of different regulations and standards related to validation activities
• Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent

• Preferred Qualifications & Skills:

• Relevant quality experience or validation experience not necessarily within a quality department
• Experience with clean, lifetime or aseptic would be appreciate
• Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
• Ability to master the key QA activities related to production, QC, maintenance, calibration, and validation in the area of responsibility
• Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well-developed relation building skills to gain trust and credibility and to build a great place to work and good social climate
• Demonstrated impact and influence

• 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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