Firoz Arsiwala Email & Phone Number

Westford, Massachusetts, United States

Greater Boston Area

Real Time Release (RtR) Digital Product:● Leading a team of Quality, Digital and ITS experts in the design of a digital product to fully automate the drug substance release process using Agile methodology.● Primary point of contact accountable for a validation strategy and realization of business value for the real time release digital tool. iObeya Visual Management:● Primary lead responsible for development and execution of a digital strategy aimed at converting manual visual management boards to fully digital tracking boards across site. ● Responsible for training of 70 end users in iObeya software. ● Business system owner to define site configurations and provide day to day support for end users.Document Management System:● Primary process owner of documentation management system for 10 Sanofi Biologics sites.● Designated change control owner for assessing business impact bi-annual system upgrades, including coordination of validation and UAT activities. ● Responsible for escalation and resolution of system issues with technical team and leadership across network of sites.● Deviation and CAPA owner for compliance issues related to the system performance impacting the business users.

One Research Drive, Westborough Ma

● Led data migration of 26,000 GxP quality document from legacy Genzyme system to Sanofi core solution across 8 sites.● Responsible for validation of interface between document lifecycle management (GEODE+) with a web viewing tool (Gibraltar) and with training system (My Learning Center).● Lead cross functional subject matter experts to develop a single system configuration across 8 sites harmonizing multiple business processes into one.● Developed training strategy of local system owners and 800 end users.● Developed global end user lifecycle document management procedure, governance procedure and user access procedure.● Managed risk identification, risk mitigation and resource planning with senior leadership across business and ITS.

Framingham, Ma

● Change owner for technical projects supporting manufacturing utilizing TrackWise quality system for changes such as –- Commissioning and Qualification of cleaning out of place cycle (COP) for product contact, buffer parts and hoses.- Implementation of instruments and equipment for GMP use: pH/conductivity meters, QC sample refrigerators, benchtop balances.- Commissioning and Qualification of storage for purification buffer from stainless steel tanks to sterile bags.● Lead deviation management teams to identify root cause, document investigation reports and develop CAPA plans.● Lead several process improvement kaizen initiatives in purification manufacturing department aimed at:- Streamlining standard operating procedures (SOP) with end user input to prevent process deviations.- Improving operator work life by implementing standard work and operator role cards.- Implementation of a training plan to enable expansion of production capacity supporting bioreactor output.

● Managed EMR functionality implementations at 11 primary and 6 specialty practices aimed at improving efficiency for processes such as: test results management, medication management, notes documentation, Medical Assistance triage, and internal communication.● Program owner responsible for developing a project plan to implement Clinical Referral Management System (CRMS) at 4 primary care and 8 specialty practices.● Developed and executed a 16-week training program on concepts of project management, LEAN process improvement and change management tools for Practice & Nurse Managers.● Coached graduating participants execute projects aimed at improving clinical and non-clinical processes that contributed in increasing CGCHAPS patient satisfaction scores and process efficiencies.

Certified Scrum Master

Certified Scrum Product Owner

Certificate In Applied Project Management, Project Management

Master Of Science, Industrial Engineering

Bachelor Of Engineering (Be), Mechanical Engineering