Specialist QA Operational

Job purpose:

FVI main activities are the filling of a broad range of vaccines in syringe and vial presentations. Vial presentations are filled on the TL1 liquid filling line and on the TL2 freeze dryer line. The filled syringes and vials are then visually inspected by automated inspection machines and manual visual inspection to remove any potential defects.

The QA specialist masters the key quality assurance activities related to production and validation, project activities in his/her area of responsibility. You will fulfill the role of QA operational specialist for the week activities.

Your responsibilities:

• Responsible for QA activities:
  • Responsible for the QA Oversight (manufacturing, validations and/or technical operations)
  • Responsible for quality decision and/or responsible for the proper escalation through on-call system if needed
  • Responsible for deviation, CAPA and Change control completion
  • Ensure that quality systems (deviation, OOS investigation, CAPA, documentation, training, change control, validation activities, maintenance and calibration activities) and cGMPs are in place and in use
  • Perform L1 audit and contribute to MPU inspection readiness through gemba and documentation review. Replies to auditors’ requests during inspections and supports the manufacturing operations during GMP inspections
  • Develop knowledge in the different processes in the area of oversight

• Responsible for the coordination/facilitation of the QA teams (the QA Specialist can be the first line leader of the QA teams or act as a team coordinator without direct reports)
  • manage team performance,
  • perform regular shopfloor presence,
  • give proper feedback to the teams (and to the teams N+1),
  • ensure the compliance on EHS topics (not only in QA teams) and contribute to develop the EHS mindset
  • contribute to the wellbeing of the team

• Promote continuous improvement mindset and use Operational Excellence tools (e.g.: STP/IPO/PSS/Fishbone/5S…) for problem solving

Why you?

Basic Qualifications:

We are looking for professionals with the following required skills to achieve our goals (must-have):

• Scientific university degree (Pharmacist, Engineer or equivalent) or equivalent by experience
• At least 2-5 years of experience in pharmaceutical/biotech/medical device/food industry or equivalent environment
• Good team player
• Good communication skills (applicable to French and/or English)
• Quality mindset

Preferred Qualifications:

The following characteristics are assets (nice-to-have):

• Good knowledge of English
• Knowledge of GMP regulated environment

• 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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