Product Expert – GSK – Waver

Site Name: Belgium-Wavre
Posted Date: Sep 28 2021

Job purpose:

Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites/MPU when applicable, with focus on the product(s) & associated process. Provides second line technical/scientific process support.

Your responsibilities:

• Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer from development to date. It includes the creation and continuous update of the process validation documentation for LVV products (Technical Risk Assessement (TRAs)/CPP/PCS) but also training to the shopfloor to elevate skills of operators and employees.

• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.

• Utilize data trending and statistical analysis to:

  • Deepen and broaden process understanding and knowledge.

  • Detect issues in process capability, such as systematic quality defects.

  • CPV trending (Issue data trending report).

  • Ensure data and trending is visible and communicated at shopfloor level.

• Support or manage following activities and escalate to appropriate governance as needed:

  • issues/risks detected through CPV, AQR/PQR,

  • investigations,

  • improvement projects,

  • product or process change controls

• Liaise with multidisciplinary functions (Product stewards, Quality Assurance QA, Quality Control QC, Engineering, Regulatory, production representative and shopfloor production teams) with focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product/process in constant state of validation

• Actively participate and represent their product(s) & processes in the relevant committee

• Support the validation/project teams to assess the product & processes impact and the validation plan (process validation)

• In charge of Product validation (write both Validation Protocols and Report) and execution

• Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Fluent in English and proficient in site local language.

• Experience in process support, e.g. Process Expert role on the shopfloor of vaccines manufacturing and/or QA/QC.

• Leads activities and in an environment that requires profound technical and scientific understanding of biological manufacturing processes

• Proven process understanding (Vaccines, GMP, Regulatory aspects).

Preferred Qualifications:

If you have the following characteristics it would be a plus:

• Sound experience of data handling and applied statistics is a must.

• Used to work in cross functional working teams

• Good communication skills

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.

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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