Sohail A. Email & Phone Number

Chicago, Il, Us

Lake Zurich, Illinois, Us

- Coordinating, performing, and assisting in the development of computerized system life cycle documentation and tasks to establish computerized systems that meet the company requirements, regulatory requirements, and industry standards. Life cycle documentation includes, but is not limited to: user requirement specifications, functional specifications, design specifications, risk-analysis, traceability matrices, standard operating procedures, installation qualification protocols, operation qualification protocols, performance qualification protocols, validation master plans, and summary reports.- Performing computer systems compliance analysis for systems with Fresenius Kabi USA, LLC policies and procedures, regulatory requirements and Fresenius Kabi Global Quality Management policies.- Authoring and reviewing of standard operating procedures associated with the compliance of computerized systems.- Conducting 21 CFR Part 11 assessments on new and existing computerized systems.- Assembling and maintaining computerized system life cycle archives.- Serving as point of contact for administering and/or processing computerized system change control requests.- Maintaining and assuring completion of computerized system change control request documentation.- Conducting training on 21 CFR Part 11, computerized system validation methods, and computerized system change control processes.- Maintaining awareness of current regulatory trends and their impact on the validation status of computerized systems.- Seeking out and recommending to management the opportunities for increased quality system efficiencies and operational improvement through modifications to current systems, implementation of new systems, and more efficient use of established systems. - Working under minimal supervision. Periodically assisting in orienting, training, assigning, and checking the work of colleagues.

Waltham, Ma, Us

Developing and implementing Software Development Life Cycle (SDLC) product quality/ process improvement strategies with guidance from a multi-functional team based on risks and opportunities.Working closely with the Information Technology and Engineering team, software testing team and business owners to increase the reliability of software.Developing test plan and test strategy and efficient documentation for ThermoFisher electronic document management systems instances for ThermoFisher internal clients.Performing periodic reviews on manufacturing equipment and laboratory instrumentation and associated software to ensure the compliance of the validation status.Reviewing backup and restore procedures and ensuring the backups and restores have been performed as scheduled.Ensuring the legacy equipment is appropriately assessed and performing 21 CFR Part 11 assessment and assigning appropriate mitigation studies to comply with regulations.Registering equipment, clean rooms, workstations and workcenters in Data Manager Client of MES.Perform OQ testing of workflows for cleanrooms to ensure the change in status of phases and transitions.Designing of recipes and configuration of workflows in Recipe and Workflow Designer Client of MES to match the paper batch record process.Working as an administrator and designer of electronic batch records for FactoryTalk MES.Designing and validation of generic MBRs to depict the process flow of a paper MBR.Implementing MES (electronic logbooks, cleanroom tablets, cleanroom workflows), QMS (Veeva Vault), EMS (MODA-EM), and BMS (Desigo).Providing input as required for PharmaSuite MES validation as well as to support business for implementation of electronic logbooks, electronic batch records, and cleanroom tablets.Implementation of Rockwell PharmaSuite MES system for electronic logbooks and electronic batch records.Designing process flow of the paper batch record to design and create recipes for electronic batch records.

Lake Zurich, Illinois, Us

- Describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.- Managing multiple deviation investigations simultaneously.- Providing follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.- Ensuring investigations withstand regulatory scrutiny and are compliant with cGMP regulations.- Working with Subject Matter Experts and Production personnel to fully understand and solve problems related to the deviations caused.- Providing technical expertise and recommending improvements for processes improvement.- Writing Impact Assessments and Investigation Reports and working within electronic Quality Management Systems (TrackWise).- Assigning corrective/preventive actions (CAPAs) as necessary in order to resolve problems.- Performing continuous review and follow-up on investigations to minimize overall product impact and ensuring the timely disposition of product that is directly affected.- Informing Management on the progress of on-going investigations, providing information to and taking direction from the Deviation/Material Review Board.- Providing support in completing SOP changes as directed by the Investigation conclusions.- Participating in and leading Deviation and Material Review Board (DMRB) and Quality Improvement Team (QIT) meetings to identify corrective actions to prevent repeat deviation recurrences. - Utilizing Word, Visio, Excel, Documentum (eDMS) and related electronic systems to complete tasks.- Maintaining compliance with company policies, training requirements, cGMPs and safety standards.- Performing related tasks/duties as assigned by Management.

Lake Zurich, Illinois, Us

• Developing Validation Master Plan, IQ, OQ, and PQ protocols and summary reports.• Developing and maintaining GAMP lifecycle documentation, including User/Functional/Design Requirement Specifications, Risk Assessments, Trace Matrices, and User and Operations Manuals• Supporting design of application roadmap from creation to decommissioning.• Performing Gap Analysis and Risk Assessments (GAMP 5, 21 CFR Part 11/820 and HIPAA & OSHA)• Designing and improving processes (software, product, washing, de-pyrogenation, filling, manufacturing, lyophilization, sterilization (steam – dry heat & moist heat, integrity filters, chemical VHP, and EO gas), sterility assurance, and packaging) to validate the product development and distribution process.• Performing Airflow Visualization studies and capturing requirements of air flow patterns from higher cleanroom class to lower, for each production area and line, to demonstrate aseptic techniques of sterile manufacturing, gowning, equipment setup and other associated activities having full compliance to the routine production.• Leading validation projects to ensure that products and processes meet with regulatory agency validation requirements, internal company standards, and current industry practices.• Investigating customer complaints and assisting management with the implementation of the corrective actions and the preventative actions (CAPA). Ensuring investigations are completed in a timely manner and cGMP compliant.Working as an administrator and designer of electronic batch records for Werum PAS-X MES.Understanding PAS-X logic and its integration with AMICI purchasing software and SedApta planning software.Creating electronic MBRs in Werum PAS-X MES.Providing support as required for Werum PAS-X validation and compliance documentation including SDD, FAT, SAT, IOPQ.Testing PAS-X tool with client build and importing MBRs from sandbox environment and testing integration scenarios.

Lake Zurich, Illinois, Us

Supporting the validation of Mettler Toledo Serialization System (a cloud based Serialization System).Working knowledge of Serialization Systems, 21 CFR Part 11, Data Integrity and GAMP 5 regulations.Interacting & communicating with clients during project meetings, active with identification of material container & closure systems. Writing, reviewing and revising packaging component specifications using formal change control process. Executing test protocols.Supporting Site Serialization Project Plan with development of package unit level and case labeling via Bar Tender label softwareWorking with material and service suppliers and providing updates to customers during material evaluation and selection process. Supporting packaging operations with material and equipment trial, test, and qualification activities. Working closely with purchasing to identify and procure project related packaging materials. Working closely with testing laboratory operations for testing and release of primary packaging materials. Creating strong presence on packaging floor to support and assist department management, mechanics, engineering, Validation, and QA during packaging and equipment and/or material qualifications. Working closely with Label Control to ensure compliance to site and market regulations and requirements. Performing basic machining math including fraction and decimal conversion, basic trigonometry, calculating dimensions and tolerances and determining missing linear or angular dimensions.Investigating deviations / non-conformance (NCR) and providing resolutions for problems and issues encountered during field execution activities.Generating risk management deliverables such as System Impact Assessments, Criticality Assessments, Preliminary Hazard Analysis Assessments, and Risk Management Reports.Investigating customer complaints and assisting management with the implementation of the corrective actions and the preventative actions (CAPA).

Kingsville, Tx, Us

Equipment and Automated Systems validation by performing IQ, OQ, and PQ on manufacturing equipment and related software.Helping the students in operating the CNC machine, programming, and transferring the G-code files for lab experiments.Creating CNC programs on a variety of CNC machines including Nisshinbo, QUEST, CONQUEST, Kitamura, MIYANO, etc.Working on Fanuc and FabriTALK controllers to program the CNC machines.Helping the professor in calibrating the machines and instruments on a timely schedule.Planning machining operations by studying work orders, blueprints, drawings, specifications, materials, machining parameters and interpreting geometric dimensions and tolerances.Performing basic machining math including fraction and decimal conversion, basic trigonometry, calculating dimensions and tolerances and determining missing linear or angular dimensions.

Hyderabad, Andhra Pradesh, In

Designing glass bottles for beverages using SolidWorks to improve the product design and development.Creating Bill of Materials using SolidWorks EPDM.Designing part drawings using AutoCAD and 3D models using SolidWorks.Carrying out Reverse Engineering to create prototypes for further design creations.Performing Finite Element Analysis (FEA) on products using SolidWorks Simulation.Performing product and process design changes as per the change control process.Entering data for engineering drawings and design reviews.Being involved with the project team for new product development activities.Coordinating product and process requirements with inside and outside departments and customers.Analyzing data inventory usage for previous years to better predict purchase quantities needed on hand.Evaluating vendors based on price, quality, reliability, and technical considerations, and maintained a vendor scorecard.Performing statistical data analysis and Design of Experiments (DOE) using Minitab.Reading and understanding blueprints and part drawings including geometric dimensions and tolerance methods (GD&T).Communicating and reporting daily and weekly project status to upper management.

Masters, Project Management

Master Of Science - Ms, Industrial Engineering

Bachelor’S In Technology, Mechanical Engineering