Specialist QA Release Trending & Compliance - New Pa(CDI)

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Site Name: Belgium-Wavre

Posted Date: Aug 19 2021

Job Purpose

Our department is responsible to release product at primary step, assure the compliance to the regulatory and follow the trending.

Within the manufacturing production unit New Pa, integrated in a team of 5 people, we offer you a non-routine position, with many interactions with our internal partners. Come and join us !

In This Role You

Your responsibilities:

• You ensure quality oversight of all activities related to the area
  

of responsibility

• You ensure batch release in a timely manner
• You ensure that deviations and complaints are reviewed and
  

handled in a timely manner

• Performs trend analysis on different quality systems to support QA Operations to further improve the systems and results
• You ensure critical topics are adequately and timely escalated to the Manager
• You represent QA in all operational meetings related to the area of
  

responsibility (staff meetings, deviation, CAPA, Change control follow-up meetings

• Contributes to local and/or transversal improvement projects to
  

ensure the compliance level is maintained in line with cGMP and GSK

standard requirements

• You provide QA support to new product introduction projects related to Release and trending activities
• You understand technical/production problems and evaluates their potential impact on product quality. Escalates complex problems to N+1
• You participate to the revue the product quality review (PQR)
• Perform Audit L1 (self-inspection) related to QA release department
  

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)
• Knowledge of GMP regulated environment
• 3 – 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
  

Preferred Qualifications

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

• French speaker (English is an asset)
• Good interpersonal relationship skills
• Good oral and written communication skills in French
• Problem solving and achievement oriented
• Team spirit
• Bulk process knowledge
  

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.

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.

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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