Job Description:
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This is a hybrid role working with a global pharmaceutical company. The primary purpose of this position is the management of the Quality System functions in relation to Deviations and CAPAs.
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The successful candidate will support the management of a Deviation system, facilitating cross-functional meetings and providing guidance and consultation to deviation stakeholders.
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In addition, the individual will collaborate with other departments on completion of investigations and root cause analysis, supporting the establishment and implementation of effective corrective/preventative actions.
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The role also involves the management of a CAPA system, managing CAPAs that derive from various processes such as deviations, internal audits etc.
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Facilitating cross-functional meetings and providing guidance and consultation to CAPA owners is also a key responsibility.
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The ideal candidate will have a Pharmacist or Engineer degree with a master's degree in quality, regulatory or scientific topic.
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A minimum of 2 + years of experience in pharmaceutical or biotechnology industries is required, along with an understanding of GxPs, quality systems and regulations (EU, FDA, ICH).
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Digital literacy in Microsoft Word, Excel, PowerPoint, and SharePoint is necessary, as well as experience with Quality Management Systems.
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The successful candidate must be able to perform independent work requiring attention to detail, accuracy and scientific judgment, with excellent interpersonal, written, and oral communication skills.
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Fluent English skills are required, with French or other languages being a plus.