Amir Birnhack

Improving customers’ TrackWise application to deliver faster, cheaper and higher quality projects.

Member of the company’s “elite” handful of Global Project Managers, overseeing top strategic clients. Responsibility for the Sandoz TrackWise project, a vast, challenging, multi-site (~70), multimillion (~4M$) global IT project, that lasted over 3 years and serviced over 6500 users. We implemented the Deviation, OOS, Complaint, Change Management, CAPA and Investigation processes including interfaces to SAP.

• Achieved a customer retention rate of over 90%, as the EMEA office Customer Relationship Manager. • Oversaw projects for the company’s biggest clients: like Novartis, Menarini, Boehringer Ingelheim, Teva • Managed a portfolio of global IT projects: multi sites (10-100), budget 100K$-2M$, duration 6-18 months and 100-3000 users. • Directed teams of Product Specialists working throughout the project: design, prototype development, reports, validation, testing, training, rollout and documentation.

Led implementation projects in Europe, Australia and the US, in companies such as Novartis V&D, Polpharma, Boehringer Ingelheim, Bioniche, Gambro, ResMed, Sanofi Aventis, etc. Executed global IT projects: multi sites (5-30), budget 100K$-400K$, duration 4-12 months and 75-200 users. Administered all the projects activities – user requirements gathering and analysis, design, prototypes development, reports, validation planning and execution, testing, training, rollout and documentation.

Executed IT projects: global, multi sites (1-10), with budget range of 40K$-500K$, duration of 3-6 months and 25-200 users worldwide. Gathered, analyzed and transferred URS’s into efficient TrackWise systems, based on the FDA’s 21 CFR Part 11 and Computer System Validation methodologies. Authored and reviewed validation documents such as URS, TDS, IQ/OQ/PQ protocols and validation plans in compliance with GDPs. Reviewed RFP’s and created Presale Demos in accordance with the requirements.