Senior Product Quality Expert

Senior Product Quality Expert

Grünenthal Group

Aachen, Germany

What the job looks like

Each day you’ll enjoy a variety of challenges, such as:

• Key contributor to Nitrosamine unit concerning regulatory CMC to execute according to applicable international standards in time and quality;
• Conception of planning and interdepartmental coordination for regulatory CMC topics in time and quality including compilation of regulatory CMC Quality work packages;
• Proactively developing, in cooperation with e.g. Quality Control, Regulatory Affairs, other Quality Assurance functions, the global regulatory CMC strategies for active substances and finished products regarding Nitrosamine topics;
• Proactively identify and mitigate potential regulatory risks or roadblocks, developing mitigation plans as needed;
• Providing advice to Grünenthal manufacturing sites, customers and partners regarding global CMC regulatory requirements amongst others for Nitrosamines considering national and international regulatory standards.

What you’ll bring to the table

To make the most of this role and truly thrive, you should have:

• Degree as a pharmacist or chemist;
• Profound experience of Regulatory CMC for NCEs, knowledge on Medical devices (Drug product combinations) is beneficial;
• Proven track record in QA and/or GMP environment especially for Nitrosamine related topics, plus in-depth knowledge of relevant national and international guidelines and regulatory requirements for e.g. EU, US & Japan;
• Longstanding experience in Nitrosamine assessments in a multinational pharma company;
• Experience in critically reviewing detailed scientific information to ensure information is thoroughly assessed, presented clearly and supported by data.

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