Mohammad Ismail

• Supervisor for the CSV/CSA team to ensure on time and compliant execution of the validation process for any changing or introductions to the tooling.
• Managing the technical implementation in IT software's and presentation of project status to leadership – along with any risks, milestones, budgetary monitoring and handling SLAs.
• Ensure that all assigned work performed by direct reports is conducted in accordance with cGMPs, SOP's, GAMP5, regulatory requirements, best practices, and established health & safety standards.
• Develop, implement, and maintain Guidelines, Policies, Standard Procedures, and tools to achieve a consistent approach to validating GxP Computer Systems in collaboration with other user groups.
• Capture the business cases for the projects, the options around the business cases and the pros/cons relating to the different options – on which leadership will make decisions in consideration of budget and other strategic inputs.
• Responsible for clarifications / escalation of unknown / new technical problems and the resolution of these with the system architects and business process owner.
• Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the vendor/suppliers to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement.
• Provide support, guidance, and advice about IT Infrastructure qualification to comply with GxP requirements.
• Assist company Leadership in implementing and monitoring progress against strategic plans to achieve the company goals and objectives.
• Responsible for leading validation efforts for a given project as a key project team member and coordinating with other team members to ensure timely completion of related tasks.
• Demonstrate high knowledge of quality management systems and practices for an organization towards IT and related data management and security controls.
• Review and approve the validation Test plans and associated validation Test reports following CSV and IT procedures (SOPs).
• Prepare validation documentation including Project Scope, Validation Plans, User Requirements Specifications, Configuration Master Plans, Test Protocols/Plans/Reports, and Traceability Matrix.
• Provide CSV related responses to inspectors/auditors. Provide day-to-day consulting in the compliance of validated electronic systems.

Leading computer system validation and IT compliance of a plant, to ensure end to end computer system validation and its implementation in line with current regulatory requirements of software applications like; SAP, Track and trace, Manufacturing and analytical standalone GxP application, BMS, EMS, MES, SAP, LIMS etc.

Leading major applications (SAP, Trackwise, LIMS (Labware), LES (Agilent), MES (Syncade), DMS, BMS (Honeywell), and LMS etc.) computer system validation activities and its implementation globally and Up-gradation of its new Versions & Patches. And many more QC/mfg. standalone systems.

• Responsible for performing the audit of data abstraction as per US Health care policy and regulation.
• Completely working on US health care policies and providing the quality work done for providers.
• Responsible for quality audit and feedback sessions on data abstraction on Athena Health and NextGen Software used by Providers (Doctors) in US

• Responsible for performing in-process checks in the manufacturing of Oral solid & liquid oral products, review of process documents stage-wise to facilitate timely release at various stages.
• Responsible for the execution of the company's supplies audits program i.e customer audits such as a GSK, J&J, Novartis, Pfizer and Astra Zeneca etc. And responsible for the execution of company's internal audit program.
• To ensure the compliance to QA and cGMP system in manufacturing plant and to verify implementation of system/procedures in co-ordination with other departments.

Handle overall shop floor QA responsibilities like from line clearance to batch release (end-to-end activities), handling of QMS and documents.