Beschreibung
Update contract templates for Quality Assurance Agreements (QAA) within Corporate Development in alignment with the different Stakeholders to optimize the contract negotiation in the course of the supplier qualification process.Project start should be at the beginning of April 2020 at the latest.
It is possible to work full-time for about 2 months at a time, but it is also conceivable to provide the number of hours in a period of up to 10 weeks in order to run the project parallel to another parttime project.
This is where we are looking for someone who is familiar with quality issues, has relevant experience in the industry, which knows regulations (GMP and QM regulations (NTH: regarding aseptic processes). A "Qualified Person" can meet the requirements, but one does not necessarily have to have this qualification.
Task 1:
- Review current QAA templates (029-QAA-Template and 029-QAA-template.bulk including attachments) available in BIs document management System IDEA for CON and initiate updates to reflect regulatory requirements (e.g. EU and FDA regulations) and consistency to BI internal procedures
- Independent optimization of the templates regarding structure, format, and content as applicable
Task 2:
- Establish new QAA templates for manufacture of biological drug substance, Advanced Therapeutic Medicinal Products (ATMPs), sterile drug products reflecting Task 1
- Develop a shortened QAA version for early clinical phases including by structuring and streamlining the existing template (tabulated presentation)
Skills / Profil:
- Master’s degree in a field like nursing, public health, epidemiology, health care administration, or some similar area of study
- At least 4-5 years’ worth of experience in a clinical setting/regulatory, and experience in the field of quality improvement as well
- English fluent
- German fluent (very nice to have)