Lead Quality Analyst / CMO Manager
Zagreb, Croatia, 10000
We Are Teva
Our Team, Your Impact
Quality Analyst / CMO Manager acts as a member of Teva External Manufacturing Quality (ExM Q) and will be responsible for review of QMS documents like deviations, CAPA associated with formulations that include various dosage forms of products including steriles supplied to TEVA by Third Party Suppliers (CMOs & BDs). Quality Analyst / CMO Manager closely interacts with other CMO Managers, Supplier Relationship Team (SRT) & the CMO ensuring that supply is not interrupted due to delay and provides timely updates on the status of the QMS documents and managing ExM Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements. Quality Analyst / CMO Manager is responsible to follow the Quality Management System of ExM organization, for CAPA management, review of deviations and coordination during internal and external audits and supportd Global/Regional Projects as applicable. This position is based at Teva ExM Zagreb office and may involve business travel on needed basis (max 40%).
How You’ll Spend Your Day
• Logging and review of the deviations related to ExM that are received from various CMO/Suppliers related to:
- Deviations including manufacturing, laboratory, etc.
- Complaints that includes investigations at the manufacturing site
• Check for the adequacy of the investigations and coordinate with the CMO, internal stake holders to get the complete / compliant investigation through Quality Relationship manager(QRM) / CMO Manager
• On site investigations at CMO’s as and when required to support business.
• Ensure proper investigation tools have been used to identify the root cause / probable causes.
• Ensure correct CAPA is provided by the CMO as per the root cause that was arrived from the investigation.
• CAPA lifecycle management and ensure on-time implementation and closure of internal CAPAs in Track wise system.
• Responsible for Audit readiness activities at ExM and management of audits.
• Track the implementation of Corrective and Preventive Actions (CAPAs) and assess their effectiveness.
• Participate in audits as SMEResponsible for driving and implementing Global Quality Projects at ExM as assigned
Your Skills and Experience
- Bachelor/Master of Sciences, preferred in Pharmaceutical Sciences
- Minimum 5 years of experience in pharmaceutical industry
- Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment
- Experience in handling Sterile and other complex dosage forms
- Knowledge on Compliance Standards and Regulation as applicable to the market
- Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites
- Knowledge and working experience with USFDA / EU and other competent authorities approved sites is preferred
- Technical knowledge on SAP (preferably ECC), TrackWise / VEEVA, QualiTeam, MS-Office
How We’ll Take Care of You
Already Working @TEVA?
Teva’s Equal Employment Opportunity Commitment