Isaac Objiler Email & Phone Number

Tel Aviv District, Israel

As an Operations Lead, I am serving as the vital link between global IT Management Operations and our specific IT department, reporting directly to the IT Management Operations unit. My role is instrumental in ensuring the alignment of our IT strategy with overall corporate objectives. I am droving the implementation of global IT processes within the department and acted as an extension of our IT department's leadership, facilitating timely decision-making, activity prioritization, and the successful delivery of IT projects. My responsibilities including:• Leading the development of the Long Range Plan, Annual Operating Plan, and Capex Management, resulting in strategic and cost-effective resource allocation.• Managing the Project Portfolio, overseeing approvals for applications and projects, and maintaining continuous tracking and reporting of the projects' status to the CIO and senior management.• Collaborating closely with the IT department manager, project managers, and cross-functional support teams such as Finance, Architects, Infrastructure, and Security to optimize operational efficiency and enhance overall performance

Israel

Leading LIMS (Laboratory Information Management System) implementation in Teva operation sites, as part of the IT operations QA.Managing all aspects of project:o Working with different Stakeholders (customers, vendor, QA department, developers and testers)o Create and Manage Project plan – timelines and reports to managemento Budget managemento Risk Management – Project and functional aspects of the system o Resources management – direct and indirecto Manage different activities of the project – Business process analyses, Technical sessions with Development team, Pilots sessions, Risks workshops and Training workshopso Leading full validation process according Global SOPs, GMP, GLP and GXP system regulatory requirements (FDA’s 21 CFR Part 11 for US and Eudralex Volume 4 Annex 11 for EU)

Israel

Responsible for the creation and implementation of version updates and enhancement in the LIMS systemIT solutions for laboratory needs for a variety of processes and requirementsValidations implementation and verifying working procedures according SOP's and regulationsManage the support group for LIMS applicationCreation of different validation documents such as Disaster Recovery Plan, Validation Master Plan, URS, FS, Test plan and Validation Summery Reports. Issuing training materials, working procedures and annual reviews for the system.

Day-to-day operational management of multi-product lab, handling approximately 140 different molecules.Prioritizing stability work-plans; managing the stability lab according to FDA, EDQM and global regulations and standards.Writing & approving Stability reports & evaluation of API's accordingly.People management and development in different areas such as Pharma and API processes, procedures, SOP's, ICH guidelines, GMP and GLP regulatory requirements.Key player at the establishment of the stability group at Teva's site in India, creating and implementing the analytical transfer process.Leading lab audits in the QC laboratory, presenting the different groups and leading the auditors through entire lab sections.

Master Of Business Administration - Mba, Management Of Hi Tech Companies

Bachelor Of Applied Science (B.A.Sc.), Chemistry