לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
We are looking for a Sr Manager, Microbiology-Quality Compliance Expert – TAPI. The main purpose of your job will be to ensure that the Microbiology laboratories, systems , procedures related to Quality Compliance System at TAPI sites is in place, securing compliance of activities, OOS investigations, Micro CCS, quality risk management, escalation of risks, and continuous improvement. Your role will include providing governance through strong collaboration with manufacturing site operations to foster excellence in inspection management and inspection readiness at TAPI sites. You will support manufacturing site remediation activities directly.   This role will ensure that each site receives the right level of support to sustain and continuously improve GMP compliance related to Microbiology and other quality compliance support, to strategize the development and overall implementation of remedial plans, to solve quality-related compliance issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance with TAPI standards. Moreover, you will foster and develop onsite Quality culture across all sites.How you’ll spend your day
•    Support the Implementation of the Site Inspection Readiness Program focusing on Microbiology labs and related areas•    Input, Review and Approval of Complex Investigations ( OOS, Deviations, Incidents, etc.)•    End to End Support for Health Authority Inspections  focused on Microbiological aspects•    Support the Implementation of Quality Risk Management•    Review and Monitor Quality Improvement Plans•    Train Site Colleagues on the Microbiology fundamentals, investigations, and Corporate Standard System•    Support Global Quality Compliance Initiatives eg; Cross contamination strategies•    Data Reliability assessments, gap evaluations, GxP data mapping in the micro labs•    Review global TAPI policies and standards and provide inputs•    Expected to spend reviewing QMS areas outside microbiology subject that related to QIPs, Data trending, signal detection, managing quality forums, leading CoPs related to Microbiology and relevant Quality management systems ( CAPA, Investigations, QRM etc)
 
Coordinates within the Compliance Team the following tasks:
•    Establish and monitor governance on data integrity requirements.•    Cooperate with other functions on Quality projects and their role out. •    Act as a quality SME and support global compliance initiatives upon request•    Participate in audits upon request.•    Fosters knowledge sharing among sites within the TAPI