Beschreibung
Qualification and Validation Engineer/CSV/IT Quality Manager
Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
Co-ordinate, manage and support qualification aspects of technical projects associated with the full life cycle of system specification, test/qualification, ongoing support, such as execution of appropriate event impact assessments, support of modifications within Pharma (parenterals & base), MD&D, Chemicals, Utilities, IM/IT and LAB
Deliver support to interdepartmental clients and witness the execution of critical qualification/validation steps if required.
Contribute to scheduling of PQ activities.
Assure review for compliance and approval of all critical qualification deliverables/documentation (QP, URS, IA, DQ, IQ, OQ, PQ, P&ID schemata & PM-Plans) as determined in system Qualification/Validation Plans.
Assure formal communication of a completed system qualification to representative Quality Assurance department by means of an Qualification Summary Report (QSR)
For new equipment assure the existence of full life cycle qualification documents.
Assures archiving of all qualification documents
Profile:
Higher degree as engineer or pharmacy technician. Minimum 5 years of experience in pharmaceutical or medical device area. Excellent knowledge of GMP requiirements. Preferably CSV expert. Fluent in German and English.