Pharmaceutical Process Expert
3 days ago
We are seeking a highly skilled Pharmaceutical Process Expert to join our External Manufacturing Technology & Optimization team. As a key member of this team, you will play a crucial role in ensuring the success of our Contract Manufacturing Organisations (CMOs) in delivering high-quality products to our customers.
The ideal candidate will have a strong background in organic chemistry and experience working with QMS, documentation, and CMOs/manufacturing plants. You will be responsible for bridging the gap between our business needs and the capabilities of our CMOs, focusing on facility, equipment, validation, and Quality Management System (QMS).
You will work closely with our CMOs to assess new facilities, implement projects, and ensure seamless collaboration. Your expertise will enable us to make informed decisions about our manufacturing processes, ensuring we meet our quality standards and delivery timelines.
Responsibilities- Develop and review project documentation, validation reports, master batch records, change requests, and deviations.
- Serve as the primary point of contact for technical process and equipment facility queries.
- Collaborate with our business teams to ensure that our requirements are feasible and aligned with our CMOs' capabilities.
- Maintain and improve the QMS of our CMOs and Novo Nordisk, highlighting areas for improvement and facilitating knowledge sharing.
- Provide expert advice and lead continuous improvement projects to enhance our manufacturing processes.
This is an exciting opportunity to contribute to the growth and success of our organisation, working collaboratively with international teams and traveling approximately 20 days per year.
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