Maya Gefen

Quality Project Manager

QA manager to work with vast experience working with industry standards and compliance with regulatory requirements.
Proven experience in creating procedures and workflows as well as improving existing processes.
Management Cleaning validation field; Process Validation field, including regulatory issues for new preparations and manage changes to existing products (by Change control system).
Dealing with suppliers of raw materials and packaging materials.
Approving process validation protocols and reports.
Responsibility for product stability process and reserved samples.
Conduct production investigations (MDR) and Laboratory Investigations (LIR) including CAPAs as part of process validation, stability process, and launching of new products.
Responsibility for Annual Product Review reports for the OSD and sterile plants (PQR/APR).
Responsibility for inspection readiness.