Teva Third Party Operations Quality Manager & Qualified Person QP 

Turkey, Istanbul, Istanbul 

191992805

• Market release operations for batches both imported and local to local products (from local CMOs)
• Ensure GDP compliance support while working at the 3rd party distribution center (sales warehouse)
• Accountable for technology transfer projects by having analytical transfers and process validations (including design of the studies, review/approve protocol and reports, attend production of validation batches as an observer etc.) executed at CMOs in timely manner.
• Support KPI reporting & evaluation and discussion at global level in Quality Councils
• Accountable for successful QMS (preferred Trackwise, Veeva) forpost-marketin quality issues such as customer complaints, returns etc.
• Identify Quality / Compliance risks at CMOs, resolve issues and minimize risks and input, review and endorse investigations in the local manufacturers
• Drive continuous improvement /CAPA processes at the CMOs through target setting, quality expert meetings, regular Business Review Meetings
• To have active role in the process/quality improvement/ technical troubleshooting projects to drive risk reduction activities to ensure product robustness, sustainability and capability at CMO.
• Maintain product risk oversight by reviewing PQR, stability data, BMR, validation report etc. and proactively drive risk reduction program
• Provide to maintain the robust quality assurance system with the company SOP & Training management
• Provide maintenance of company QMS to ensure compliance to local and global regulations
• Manage/follow up new & cuurent regulatory compliance necessities & ensure changes and improvements in the QMS accordingly
• Support global QMS projects on behalf of Teva Affiliate
• Support Vendor Qualification and Maintenance

• Bachelor’s degree in pharmacy/chemical engineering/chemist or equivalent scientific degree
• In pharmaceutical industry, minimum 7 years of experience in a similar position in local manufacturing related business models or manufacturing environment itself.
• Background in R&D or/and Quality Control Laboratory is strongly preferred in parallel with Quality Assurance. Proven experience working with technical and operational teams troubleshooting.
• Experience in production & method validation processes, quality oversights in different culture local manufacturers, technology transfer projects, knowledge about the technology of different types of finished product and raw material characteristics such as sterile, non-sterile, non-beta lactams and beta-lactam-penicillin, biotech etc.
• Excellent planning, co-ordination, communication skills
• Ability to manage multiple tasks and strong daily follow up skills.
• Energetic and committed to continuous improvement, meeting evolving Quality compliance expectations.
• Result-oriented, analytic, and well-disciplined.
• Advanced level of English, good knowledge of MS Office applications and being experienced with computerized Quality Systems is preferred.
• Ability to work as part of a team within an international and multicultural team at various level of organizational leadership.
• Knowledge of local current and upcoming legislation and current Quality Standards and advanced knowledge of cGMP requirements
• Advanced understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation etc.
• Advanced negotiation, interpersonal and presentation skills
• Change Management Experience within the complex MoH, Vendor, CMO environment
• Able to travel to local contracted manufacturers

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