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Computer system validation

Rixensart
Pauwels Consulting
Publiée le Publiée il y a 14 h
Description de l'offre

Join a progressive environment where your quality assurance expertise will play a vital role in the implementation of state-of-the-art automated systems in the
pharmaceutical sector
. Our client is looking for a skilled professional who can ensure compliance and quality throughout the automation lifecycle.

As an ideal candidate, you are a detail-oriented
Quality Assurance Specialist
with a passion for maintaining high standards in a complex work environment. If you are analytical and enjoy collaboration, this role is well suited for you.

* You ensure that business processes, equipment, and computerized systems meet compliance standards.
* You provide quality assurance expertise and support to stakeholders and teams.
* You collaborate with interdisciplinary teams to uphold quality standards throughout the automation lifecycle.
* You review and approve relevant documentation related to GCLP/GCP and CSV activities.
* You manage technical complex problems, evaluating impacts on quality and escalating issues as needed.

What are we looking for?

* You have at least
0-3 years of experience
in Quality and CSV in the pharmaceutical or biotech industry.
* You are familiar with computerized systems validation and equipment qualification.
* You possess knowledge of compliance rules and recommendations for the CSV area and business in pharmaceutical industries.
* You have expertise in risk management principles and tools.
* You possess strong knowledge of quality systems such as Deviation, Change Control, and CAPA.
* You are a clear communicator with good presentation skills.
* You excel in managing stakeholders and building relationships in a matrix environment.
* You are proficient in
English
(reading, speaking, and writing).
* You effectively manage time and prioritize tasks.
* You have an analytical mindset and are comfortable with IT and computerized system tools.

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