Examensarbete, 30 hp (två studenter)- Optimering av referensprovshantering inom Site API, AstraZeneca Södertälje
Core
Investigate and optimize the handling of reference samples for active pharmaceutical ingredients (APIs) to ensure regulatory compliance while reducing non-essential activities.
Role type
Academic project (Master's/Engineering) in Quality Assurance
Builds
Process optimization proposals and change control documentation for reference sample management
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
research
Required skills
Regulatory analysis, GMP knowledge, Process mapping, Gap analysis, Project planning, Technical writing
Preferred skills
Experience with EudraLex/ICH guidelines, Data quantification
Technologies
EudraLex Volume 4 Part II (ICH Q7)
Responsibilities
Conduct literature study on regulatory requirements, Map current sample handling processes, Perform gap analysis between requirements and current state, Quantify potential efficiency gains, Propose updates to local instructions
Seniority
Academic project (30 ECTS, 2 students)