For the drug development and supply department at our client, we are looking for a QA expert, interested in QA process improvement and optimization.

The Discovery, Product Development & Supply (DPDS) organization strives for a full understanding of the release requirements and post-release behavior of a Drug Substance (DS) and Drug Product (DP), providing expertise and support to the wider company whenever critical issues arise.

In this role, as a QA expert, you will be assigned to a team of international QA experts, and in charge of analyzing, improving, and optimizing the current processes in use.

More specifically, this involves analysis of inconsistencies or differences in QA processes in use at various sites, and proposing a new unified strategy that is in line with company policy, ISO, and FDA requirements, whilst still assuring flexibility and achievability of critical product supply.

Additionally, you will be called upon to help debottleneck current blocking issues (e.g. QC OOS, interruptions in product transfer between sites arising from QC/QA differences) with specific drug substances, and providing support in reaching agreement between production sites and global QA and supply.

Responsibilities:

• Interacts with the team to identify current issues, blocking points, inefficiencies, and delays
• Proactively searches out stakeholders and experts, proposes solutions, and drives implementation of new and/or improved procedures
• Leads and participates in meetings as appropriate to support team goals
• Coordinates globally as the projects often span offices and time zones
• Participates in trainings and continuous improvement initiatives
• Ensures compliance with all relevant regulations, GMP and safety
• Interprets the regulatory guidelines for quality and EHS and ensures their compliance

Qualifications:

• Master’s degree in Pharmaceutical Sciences, or equivalent through experience
• Profound knowledge and experience in use of pharmacopeia and compendia, especially at handling revisions and nonconformities
• Working knowledge of operational facets of drug production, as well as QC and regulatory
• Independent working skills and self-starter mindset. Willingness to go out and find issues and their root causes, without strict guidance
• Strong planning and tracking skills, well organized and capable of handling multiple projects with respect to priorities and resources
• Excellent organization, communication skills in a team setting
• Understanding of regulatory guidelines for quality
• Flexible and adapt quickly to constantly evolving business needs
• Good written and verbal communication skills in English next to being fluent in Dutch or French
• Practical experience in industry and knowledge of GMP regulations are an asset
• “Can do” mentality and taking full ownership of your work