Validation Manager (m/f)

REFERENZNUMMER:

362174/11

IHRE AUFGABEN:

-Assure compliance of validation activities with cGMP as well as with internal policies and procedures
-Write and execute process validation, qualification protocols (IQ, OQ, PQ) and reports
-Write and transfer SOP
-Write process Risk Assessments, critical component assessments, Requirement Tractability Matrix and reports
-Co-ordinate qualification execution activities, including external vendors, internal departments, organizing materials, etc.
-Manage associated qualification deviations and CAPAs (including opening, resolution with supplier and closure)
-Participate in the creation and review of process Risk Assessments

IHRE QUALIFIKATIONEN:

-Experience in validation and equipment qualification
-Competent with current FDA and EU regulatory regulations and best practices, including GAMP
-Team player with good communication skills
-Fluent in French and English oral and written
-Knowledge of pharmaceutical (solid dosage) facilities advantageous
-Solid dosage experience and process validation associate advantageous

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist