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Teva Pharmaceuticals is looking for a qualified and motivated candidate for the role of Manager Quality Compliance (Nitrosamines Project Lead) based in Sofia.

Main responsibilities

Quality Compliance processes:

  1. Support and participate in establishment and monitoring of Compliance oversight for TPO EMEA Quality. Setting up and coordinating Compliance processes with Teva Global and corporate function as well as the different quality unit of the TPO EMEA Organization.
  2. Inspection and audit management.
  3. Training and Knowledge management.
  4. Quality Management Systems.
  5. Metrics and Trends Reporting.

Nitrosamines Project Management Focus:

  1. Organize and lead project meetings (e.g. weekly, Monthly, Quarterly, Nitrosamines Steering Committee).
  2. Ensure that data compiling given by TPO Quality EMEA is part of established database and in ready for reporting condition.
  3. Preparation of reporting data in charts, diagrams and presentation decks.
  4. Monitor and update files for multiple aspects of the project.
  5. Follow-up and send reminders to the responsible teams or escalate if required.
  6. Ensure successful completion in full on time of Step I, II and III of the project.

Nitrosamines Project Data Maintenance:

  1. Ensure mapping out of the existing systems and databases for Nitros relevant master data.
  2. Perform gap assessment between the databases, initiate and perform corrections.
  3. Ensure consistent update of Nitrosamines Data and relevant databases.
  4. Maintain and improve user experience of such databases.
  5. Train and encourage the use of such systems.

Main requirements

  • University diploma in life science or pharmacy required, or equivalent work experience;
  • Quality Assurance/Compliance and experience in pharmaceutical/Biotech or Device industry experience;
  • Experience with pharmaceutical database systems as a user and administrator;
  • Nitrosamine background knowledge and Project Management will be considered as an advantage;
  • Good organizational skills, including attention to detail and multi-tasking skills – Ideally expertise in Third Party Manufacturing field;
  • Ability to prioritize effectively, manage multiple tasks simultaneously and thrive in a complex environment with multiple priorities;
  • Ability to effectively communicate both internal and external to Teva;
  • Extended software knowledge including Microsoft Excel (pivots, advanced formula usage), PowerPoint, Visio and preferably SAP, TW, GI, Glorya;
  • Ability to work independently- quick-thinking, fast learning abilities, problem solver;
  • Results orientation;
  • Strong verbal and written communication in English.

The Offer

  • Team spirit and multinational working environment;
  • Trainings and career development opportunities;
  • Compensation linked to performance and experience, benefits;
  • High-tech working conditions and modern office space.