Minőségbiztosítás állások, munkák

• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...

• Responsible for performing laboratory-based activities and processes
• Tracking, inventory, sample processing, and transport of biological samples from clinical and non-clinical trials
• Manage associated metadata, and ensuring that lab activities fulfill customer needs

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• Author, own and maintain internal guidance and training documentation
• Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

Provide essential guidance to laboratory colleagues on the planning, execution, and conclusion of analytical tests for in-process and intermediate analytics...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities