Expert GMP/GDP QA Affiliate Support

Expert GMP/GDP QA Affiliate Support

Daiichi Sankyo Europe

Vienna or Munich

The Position:

The Quality Expert – Daiichi Sankyo EU Affiliate Support will be responsible to provide operative support to the local QA Managers of a defined country cluster. In addition, he will support the local Responsible Persons according to the European GDP Guideline.

Roles and Responsibilities:

• Registration and follow-up of complaints, returns, deviations, changes, and CAPAs;
• Support the Quality Manager/RP in updating GxP-relevant SOPs;
• Management and administration of trainings;
• Support of customer qualification activities;
• Participation in self-inspections;
• Assist in preparation of annual management review;
• GDP product release support;
• Support of country-specific QA projects;
• Deputize local Quality Manager/RP.

Personal Skills and Professional Experience:

• University/FH/Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Chemistry, or a comparable program;
• At least 2 years of relevant work experience in the pharmaceutical industry in Quality Assurance and/or Quality Management;
• Knowledge of European GMP/GDP regulations;
• Team player with high quality consciousness, accurateness, reliability, and a solution-oriented mindset;
• Very good written and verbal communication skills in English; additional European languages (e.g. Italian, Spanish, French) are an advantage.