Specialist QA operational PSMCC

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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 Operational PSMMC

The purpose of the role is to assure and maintain the organization of the activities linked to the quality oversight of the manufacturing activities in the WN-17 building (PS-MMC) for HPV and RSV production. By the quality oversight of the manufacturing process and the use of quality systems in place, ensure the quality of the product and the supply of the bulk product in a timely manner

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
• Participate the implementation of the quality systems in the new production building to assure compliance of consistency campaign and the commercial production
• Participate in the management of team performances through regular shopfloor presence, define action plans, ensure the implementation and measure through KPIs within his areas of responsibility
• 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 by using Operational Excellence tools (e.g.: STP/IPO/PSS/Fishbone/5S…) on day to day activities
• 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 the operational QA 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
• 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
  

This job opportunity is a permanent contract not opened for relocation.

Why you?

Qualifications & Skills

• University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer pharmaceutical
• Minimum 5 years in the Pharmaceutical/Biotech industry with significant experience of GMP
• French fluent and professional writing and speaking in English are a must.
• Preferred knowledge of vaccines and/or immunology process and products (manufacturing).
  

Preferred Qualifications & Skills

• Minimum of 1-2 years of experience in manufacturing and/or QA within the pharmaceutical industry.
• Leadership, decision making, critical thinking and analysis of issues, impact and influence, innovative thinking, engage people, achieving excellence
• Li-GSK
  

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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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