Leading the team of TAPI Quality compliance & support
Ensure that each site within TAPI receives the right level of support to maintain and enhance GMP compliance, to solve quality related service issues, to identify areas of improvement for quality operational performance in line with business needs and in accordance to TEVA standards.
Foster and develop onsite Quality culture.
Lead the teva api Quality compliance & support team of highly professional specialist
Member of the teva api Quality Leadership Team
Ensure the corporate Quality Management System (QMS) is implemented and the local Quality Management Systems is up to date.
Responsible for the management of the teva api Quality Council
Ensure the timely availability of data to the reporting portals and provision of teva api reports,
Coordinates within the Compliance & Support Team the following tasks:
Coordinator Role of the Notifications to Management process within the teva api and the global Notifications to Management process, both in accordance to global standard including QAM and MAC meetings
Support of execution and coordination of recalls
Primary contact role for the distribution and implementation of corporate standards within teva api
Performance management and reporting
Coordinates the capacity of the compliance specialist in partnering with the sites to remediate any gaps identified in compliance, towards the QMS or in quality related service Site compliance reviews
Investigation and remediation of non-compliances to corporate QMS
Oversight to the evaluation of effectiveness of the corrective and preventive actions.
Quality risk assessments
Data integrity governance
Ensures continuous improvement of compliance and performance Establish and monitor governance on data integrity requirements.
Establish and manage the teva api Change Control Forum
Degree in Chemistry, Biology, Microbiology, Pharmacy or similar
Demonstrated knowledge in cGXP regulations.
15+ years’ experience in GMP environment, continuous professional development, cGXP regulations
10+ years’ experience in managerial tasks, to lead a quality department or organization
Very good understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Microbiology, Documentation et
Sound knowledge of regulatory standards and guidance in Pharmaceutical Industry and expectation of global regulatory bodies, specifically FDA, teva api, PMDA and Anvisa requirements
Knowledge of Quality Systems, product types and manufacturing operations
Ability to understand and execute against Teva Quality Management System
Fluent in English