לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
Position responsibilities include Quality oversight for Manufacturing, Packaging and Laboratory Operations to ensure a mature culture of quality, compliance with regulatory requirements and quality of products.
This oversight includes but is not limited to: the establishment and execution of procedure; Establishment Licensing, Quality on the Floor activities including audit and release; handling of laboratory, deviation and complaint investigations; CAPA creation and implementation; trending and metrics, compliance with regulatory requirements; verification that equipment, facility and utility systems are maintained, calibrated and qualified in accordance with established requirements.
Lead the development, standardization, implementation, monitor effectiveness and continuous improvement of the Quality Systems, global and local compliance. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices.
Key Responsibilities
•    Leads the QA organization on site – Quality Compliance, Quality Systems, QP and Quality Assurance.
•    Ensure a current Quality Management System is in place and continuously improved
•    Ensure products are manufactured, released and distributed in accordance with cGMP requirements and registered specifications.
•    Assess and Mitigate Risks– Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply
•    Promote a Sustainable Culture of Quality—Create, develop and maintain a culture of enhancing quality throughout the entire site operation.  Create a space where people can speak openly and are encouraged to present new ideas to improve quality
•    Maintain strong partnership with Operation, Supply Chain, Engineering, MS&T
•    Provide effective Quality leadership during internal, customer and Health Authority inspections
•    Ensure that Quality KPIs are meeting pre-defined targets, ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically