QA e-Compliance Contractor (m/f)

REFERENZNUMMER:

284749/11

IHRE AUFGABEN:

-Provide QA eCompliance oversight in order to migrate data and computer systems to other companies that have purchased them along with their associated business processes
-Support QA eCompliance with regard to project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements
-Provide QA support for GxP impact computer system implementation projects
-Ensure that projects, systems and processes meet the requirements of the client's quality manual
-Provide excellent QA operational support to IT departments, including assistance with GxP decision making, change control review and approval, SOP review and approval as well as review/approval of other GxP-related deliverables as needed

IHRE QUALIFIKATIONEN:

-B.S. in Computer Science, Engineering, or other similar scientific degree
-Very good knowledge in a GxP environment with a thorough understanding of computer validation
-Knowledge in validation of cloud solutions is beneficial
-Knowledge in 21CFR, Part 11
-Knowledge in EU Annex 11
-Knowledge of typical IT processes
-Knowledge of GAMP5 and its full lifecycle
-Project management skills
-SAP skills
-In-depth working experience in a QA role in a GxP environment

WEITERE QUALIFIKATIONEN:

Quality manager, Compliance manager