לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
This position is responsible for leading and maintaining the site Internal Audit Program and providing support during business partner audits and regulatory inspections.  This position supports teams using trend and investigational data to create value through process improvements and failure reduction activities and provides representation for quality department on cross functional teams.  In addition, provide support to monthly quality metrics, Site Quality Council, Compliance Gap Assessments, Inspection Readiness, Deviations, CAPAs, Complaints and other miscellaneous quality projects.
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary.  Any non-essential functions are assumed to be included in other related duties or assignments. 

•    Compliance with Internal Audit Program schedule
•    Generate, Collect and Upload Monthly & Quarterly Metrics for Quality Council and Site Quality Risk Map
•    Prepare supporting documentation, facilitate and attend the Site Quality Council, present area results and prepare meeting minutes
•    Prepare Site Quality Councils presentation on time
•    Provide High quality support for Compliance CAPAs and investigations. Help develop and conduct the site Internal Audit Program.
•    Provide support during Teva’s GRA Audits, Third Party Audits and outside Regulatory Inspections (e.g. FDA, MHRA, EU, Anvisa, etc.).
•    Provide support to Site Inspection Readiness activities.
•    Support Complaint investigations
•    Assign, monitor and close audit and Compliance CAPAs in the Quality System.
•    Perform gap assessments to ensure compliance with regulations.
•    Provide support for site investigations.
•    Prepares and submits reports, standards, and other documents as required.
•    Engage in and promote Quality & Operational Excellence.
•    Coordinate with other departments and perform investigations, and process change controls.
•    Prepare APR contributions for complaints, investigations to show product performance and determine compliance
•    Coordinate with other departments to complete investigations and reports
•    Review and approve protocols, reports and change controls
•    Provide guidance and coaching to employees on GMP, inspection readiness and quality systems
•    Responsible for completing all training requirements and maintaining 100% compliance with all assignments.   
•    Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies, procedures, state, federal and local laws, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions. 
•    Responsible for performing additional related duties as assigned or required by business needs.