QC Analytical Expert
Summary
Quality Control Analytical Expert in a pharmaceutical lab, owning HPLC/UPLC/GC methods, performing root-cause analyses, and ensuring compliance with pharmacopeia and cGMP standards.
QC Analytical Expert
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Location: Geel
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Grade: L1-2
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Hiring Manager: Wim Van Dam
About the job
As part of a replacement, we are looking for an enthusiastic, driven Quality Engineer within PCU release & stability. Employment will be within the Quality Control lab at Cipalstraat in Geel.
Main responsibilities:
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You are the method owner of specific QC methods. In this role, you are the primary contact person within QC operations in case of troubleshooting and method improvements.
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You are responsible for performing root cause analyses and impact assessments based on method-specific knowledge in the event of out-of-specifications and/or deviations from established procedures.
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You are responsible for method performance evaluations, and potentially related lab trends and trend investigations.
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You are responsible for performing method validation/transfer experiments during the implementation of new methods in QC Chemistry.
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You are responsible for ensuring compliance with the pharmacopeia.
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You are responsible for the compliance review of QC procedures.
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You manage change control, where the necessary actions must be defined in the QMS system and executed according to plan.
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You work independently on assigned projects within a well-defined timeframe.
This position primarily involves working in day shifts (flexible hours), but flexibility in hours and days may be required. After a training period, there is the possibility to work from home 1 day a week.
About you
Given the content of this position, we are looking for the following profile:
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You have at least a Master's degree in Life Sciences or equivalent through experience.
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You have knowledge of analytical (HPLC, UPLC, GC,...) and/or biochemical techniques (cell-based, cIEF, CE-SDS).
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You have an interest in learning and/or deepening your knowledge of other analytical and biochemical methods.
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You have an interest in method validation and verification, including the statistical evaluation of data.
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Knowledge of Pharmacopeia is a plus.
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You have a very good command of English, both written and spoken.
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You possess good technical writing skills and are able to draft protocols and reports.
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You possess excellent knowledge of cGMP.
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You are a team player and have good communication skills.
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You have excellent analytical and problem-solving skills.
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You are accurate and have an eye for detail.
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You are flexible and willing to take on various tasks.
Why choose us?
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Working in a high-tech environment
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Utilizing various training opportunities
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Working in a great, collegial atmosphere
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Choosing a dynamic sector with growth prospects
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at !
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at !
The salary range for this position is :€63.102,95 - €94.654,43
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.