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Advanced Quality Advisor
4 weeks ago
The position
As a SOP Simplification Specialist, your key areas of responsibility will be to:
Simplify SOPs by cutting complexity and enabling process simplification.
Participate in projects to develop processes and lead activities related to SOP writing and process mapping.
Ensure simplicity and deliver user-friendly instructions by providing feedback on SOP drafts, coaching, and writing new SOPs.
Drive the development of new or re-written SOPs and participate in digitalization projects.
Become an expert in the document control process and be the Area Process Manager for the corporate process group for content control.
To be successful in this role, you will need to collaborate with stakeholders from various business areas within research and development. This is a unique opportunity to develop knowledge of many processes and gain skills in Quality, learning about external requirements for the pharmaceutical industry and how to implement them in SOPs.
Qualifications
To excel as a SOP Simplification Specialist, we are looking for someone with the following qualifications:
Msc degree within science, engineering, business management, or similar and experience in clearly written documentation
Experience from the Pharma industry in basic GxP requirements, developing instructions, training materials, or user guidance learning new information, and writing about it
Effective writing skills and ability to communicate complex information in a simple way
Excellent facilitation skills to lead efficient workshops with people from diverse professional backgrounds
Strong project management skills including stakeholder management and process visualisation to enable optimisation
Proficiency in MS Office Tools; good understanding of AI-related tools (e.g., ChatGPT, M365 Copilot) would be an advantage, and knowledge of the Veeva Vault Platform is an advantage
On a personal level, you are team-oriented with a high degree of flexibility and change readiness with experience in collaborating with change management professionals, also you have a personal drive, impact, and leadership, with a mindset to challenge the status quo and positively deal with stakeholder resistance, and ability to build relationships and motivate and engage stakeholders
About the department
The SOP Simplification position is in the RDQ Operational Excellence department, which is one of the three sister departments in R&D Quality Operations. Our department is responsible for supporting Research & Early Development (RED) and Development (DEV) with our QMS expertise. We also support cross-organizationally in R&D Quality, strengthening the implementation of RDQ strategic initiatives such as digitalization, continuous improvements (cLEAN), and data analysis.
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