Manages the Compliance unit, overseeing the professional and personal welfare of the personnel
Supports the site on issues concerning cGMP requirements, regulations and guidelines for the different markets – USA, EU, Israel etc
Follows up on new and updated regulatory concepts and demands and supports their introduction and implementation into the site
Leads quality improvement projects
In charge of Inspection readiness. Prepare and accompanies external regulatory and other inspections. Prepare and oversees responses to external inspections. Support Paper Audits. Oversee the implementation of follow ups and corrective actions committed by the site as a result of external audits and evaluates effectiveness of corrections
Ensure the implementation of Standard Operating Procedures relating to Regulatory Compliance and compliance with the requirements of Good Manufacturing Practice (cGMP)
Ensure that deviations pertaining to the Regulatory Compliance issues are reported and investigated and their effect on product is assessed and documented. Ensures that corrective and preventive actions are effective
Ensure the correct implementation of the change control procedure pertaining to the Regulatory Compliance activities so as to assess and prevent unintended adverse consequences resulting from changes
Prepare and lead Quality Council (Management Review) meetings, lead Quality issues and trends discussion
In charge of Internal Audits plan preparation and execution
Oversee CAPA and CAPA management at the site
Oversee Change controls management at the site
In Charge of Gap Analysis for Corporate standards performance
In Charge of Vendors qualification process and documentation, Service Providers, Contracts laboratories and Consultants qualification and documentation
In Charge of Change Controls, CAPA, Compliance projects management
Manages Cleaning Validation and Cross contamination Quality Activities. Oversees the review and approval of Cleaning Validation and Cross-contamination documentation
Oversee Vendors qualification documentation preparation for the inspections