Sr. Ba It Project Lead/data Integrity And Compliance Resume
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SUMMARY:
- Compliance and Change Management Project Manager with experienced as an Internal IT Auditor.
- Creates strategic alliances with organization leaders in order to effectively align with and support key business and quality initiatives.
- Extensive knowledge of Laboratory and Manufacturing Processes, System Administration, Software Development Life Cycle principles (SDLC), Enterprise platforms, 21 CFR Part 11 Compliance and Change Management Policy/program development, cross - functional team management and Project Management,Highly level Project Management Data Integrity and Business/IT process Improvement, Data integrity and IT Compliance Process improvement.
PROFESSIONAL EXPERIENCE:
Confidential
Sr. BA IT Project Lead/Data Integrity and Compliance
Responsibilities:- Project Lead for Data Integrity, Business Case Development, Architectural and Technical Business Analysis for Global Data Integrity and Business/IT Process improvements.
- Creation of Project Deliverables
- Project Planning. Financial planning and Business development.
- Present and Build Business Cases for Present and Future technology solutions.
- Data Integrity Solutions for Corporate Compliance and Regulatory Compliance.
- Business analysis for how Business Opportunities and goals will be met using possible future solutions to meet Corporate and Regulatory Requirements
- Resources tracking and collaboration with various areas of IT and Business spaces.
- Gap Analysis Audit and review of all Validation Deliverables, SOP’s, PM and all Qualification for the lab and Manufacturing space.
- Demonstration, Training and review of new possible software packages.
- BID and Background investigation of current Processes and defining possible future business cases and remediation efforts.
- Support Solution Delivery and Architecture support of Business demands and requirements.
- Technical Request Review and Business requirement vetting and client interfacing for Solution and Business case development
- Provided technical and Project management experience for Cyber Attack recovery effort.
- Global Validation and Implementation Planning for Remediation and Data integrity Efforts with regard to Standalone Lab systems
Confidential
Project Lead/Validation
Responsibilities:- Project Lead for Lab Shutdown and Remediation effort from the Melrose IL lab to the Summit West relocation in NJ.
- Gap Analysis Audit and review of all Validation Deliverables, SOP’s, PM and all Qualification documentation for Standalone systems.
- Vendor interfacing and scheduling,
- Implementation and Validation of all systems to be Remediated from the Melrose IL location
- Maintains and creates Change Controls and Validation Documents Updates.
- Training of employees for all aspects of Lab Application use.
- Utilizes Industry knowledge and expertise to assist with delivery management of GXP and SOX compliant systems and process.
- Corporate Customer service for Deployment initiatives with regard to NJ Facility roll outs.
- Validation and IT Compliance for Project support for all standalone systems as well as process improvements
- Assistance with SOP and Deliverable creation.
Confidential
Project Lead/ Technical Manager IS Consultant Empower
Responsibilities:- Maintains Customer Service excellence for client sites across the globe for Confidential
- Maintains and creates Change Controls and Validation Documents Updates.
- Training of employees for all aspects of Empower use.
- Utilizes Industry knowledge and expertise to assist with delivery management of GXP and SOX compliant systems and process.
- Corporate Customer service for Deployment initiatives and Metrics analysis with regard to Global Empower roll outs.
- Custom field creation and report building for Empower 2 and 3.
Confidential
Technical Manager
Responsibilities:- Internal Audit review of Changes related to all aspect of Pharma Business from financial to GXP.
- Internal Audit of all IT Compliance documentation including SDLC Validation documentation.
- Project Planning including but not limited to regular Client interfacing, Budget and financial planning, and presentations for additional head count and business opportunities.
- Change management review for IT Changes and documentation.
- Quality Regulatory Process Improvement management including new internal Training program to improve business communication and processes.
- Maintains Customer Service excellence for HCL at various client sites across the globe via Process improvement and client facing.
- Tracking of KPI’s for continued Customer Excellence and creation of Actions Plans.
- Utilizes Industry knowledge and expertise to assist with delivery management of GXP and SOX compliant systems and process.
- Corporate Customer service for Change Management initiatives and Metrics analysis.
- Change Management Project Lead responsible for Implementing Mentoring and Training Program for Quality Assurance initiatives for the client.
- Review of Changes related to CSOPS, CDR, ALIGN, EMPOWER, JD Edwards, PCL, and Quality Portal, eSTARS and many other GXP and GCP applications for Quality Assessment.
- Review of employee excellence and Head count for continued Customer Service Improvement,
- SOX compliance review and process improvements.
- Manager of consultants and vendor for site projects.
Confidential
Senior Manager System Specialist
Responsibilities:- Responsible for the validation of computer and automated systems ensuring compliance to required regulatory requirements.
- Maintains systems and processes developed for computer and automation systems validation up to date and compliant by working with Business owners and Department heads.
- Conducted follow up departmental IT audits.
- Member of team conducting IQ Quality and Compliance audits.
- Technical owner and Senior Manager of all GXP compliant systems and IT Compliance for Confidential .
- Internal Audit of all IT Compliance documentation including SDLC Validation documentation. Site Validation planning
- Develop SDLC validation documentation/deliverables as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc.).
- Reviews and approves all documents prepared by the validation team, other departments and contractors (e.g. test plans, impact assessments, change controls, etc.) that deal with System Compliance and System changes.
- Oversees execution of qualification protocols as required and preparation of reports of executed protocols.
- Initiated and implemented change control activities in accordance with site procedures for GXP Compliant systems.
- Responsible for Risk assessments and Remediation of any system that do not meet GAMP and 21 CFR Part 11 requirements
- Proactively resolved conflicts between compliance requirements and project/business constraints.
- Co-ordinate qualification activities with engineering, construction, validation and commissioning activities.
- Provided guidance on all activities related to computer and automation system validation.
- Through Periodic Review and Quality System review recommended improvements.
- Investigated and resolves problems which occur and determine solutions for software systems and Quality Systems.
- Hiring of Consultants and Vendor contract review.
- Participated on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups in Confidential .
- Project Management of all Validation Projects and Companywide IT Compliance initiatives.
- Coordinated and executed training of required personnel on the computer and automation systems validation procedures and methodology.
- Contributed directly to the completion of projects through the management of assigned contract personnel or internal personnel, if applicable.
- Documentation and Data retention Compliance audits.
Confidential
Senior BA/LIS Administrator
Responsibilities:- Responsible for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
- Tier 1 support for all of Teva USA laboratories systems and temperature monitoring systems and response Team.
- Coordinator for all Altiris tickets for North America
- Created SDLC deliverables and test scripts for compliance with 21 CFR 11 and ISO requirements as well as approval for the same.
- Member of IT audit team.
- Assisted with Server backups and Desktop support functions.
- Software and laboratory Support to REES Centron SQL, Empower, Labware LIMS, SDMS, ELN SQL LIMS, IDM, OMNIC, Micromertitics, Bruker optics, UVWINLAB, TotalChrom, Open lab and ChemStation Software platforms and servers.
- User support and Altiris ticket resolution for data acquisition software.
- SDMS, ELN and Vision Publisher Lead Support Analyst.
- Enterprise system implementations and support.
- Special concentration in Empower support including but not limited to troubleshooting, installation and user account support
- SQL LIMS and Labware LIMS product support and Administration.
- Training of laboratory personnel on software and SOPS.
- Production of protocols and training of employees for newly implemented Lab Information Systems.
- Setting up of user accounts and data management.
- Software and Laboratory Support to all Lab Information Systems Software.
- Remediation of all non-validated systems and initial installation document processing.
- Change Controls for new upgrades and new Validated Systems.
- Responsibilities with regard to LIS during Plant and facility shutdowns.
- Primary LIS Liaison for all of NJ, NY and PA Confidential USA sites to vendor and FDA auditors.
- Internal Audit of all IT Compliance documentation including SDLC Validation documentation as well as Site and facility audits with Regulatory Compliance.
- Volunteer Regulatory Compliance site audits.
- Lead for Empower 3 and Labware LIMS global implementation Project.
- Manager of consultants and vendor for site projects
Confidential
IS Consultant
Responsibilities:
- Backing up of servers for Empower and Updating of Laptop and Desktop Securities.
- Troubleshooting and verification of data transfer of Lace 32 boxes, Acquisition servers and instrumentation.
- Mapping of network drives and installation of software.
- Updating of Windows security, anti-virus and adware programs for all PC's and Laptops.
- Troubleshooting of chromatographic and instrumentation problems related to Empower Lotus Notes, and Chemstation.
- Assisted in setting up reports in Crystal report (Trackwise) and Empower.
- Desktop Support and Tier 1 support for laboratory systems and hardware.
Confidential
Analytical R&D Senior Chemist
Responsibilities:- Responsible for review of completed tests and training of all new employees.
- Initiation of OOS investigations.
- All Raw Material Testing and training of employees on USP, NF, BP, and EP methods
- Communication with third party vendors for scheduled and random repairs for all instrumentation
- Creation of Raw Material Specifications and assistance with updating RM methods.
- Ordering of supplies as far as chemicals and Instrument maintenance for the laboratory.
- Reviewed of specifications, SOP’s and Methods set in LIMS and Documentum
- Filling out batch records and COA for all finished products in production.
- Send out samples for outside testing.
- Documentation review of logbook and analyst testing.
- Testing of RM Development samples and setting specifications for incoming Raw materials.
Confidential
Senior Critical Care QC Analyst
Responsibilities:- QC testing of blood products, standards, cleaning agents and mobile phases for various QC for production and formulation
- Microbial content testing of all products as well as environmental studies of equipment used in production and work environment.
- Document review for other analyst’s work and value assignments for products inserts
- Troubleshooting and regular maintenance of all instruments used for testing, including but not limited to instrument calibration, replacing of electrodes, mobile phases, gas take removal, and blood run analysis.
- Training of employees
- Blood Drawing and Internal audits of Laboratory and Instrument PM and scheduled maintenance.
Confidential
Consultant Senior Scientist
Responsibilities:- Testing reporting results for Chlorine titration and Karl Fischer for QC testing of various stability samples.
- Calibration of instruments and QA of documentation for other scientists.
- Documentation review
- Ordering of supplies for lab and general office use.
- Training of new employees on test methods and cGMP.
Confidential
Consultant Senior Scientist
Responsibilities:- Responsible for review of completed tests and training of all Junior Chemist and new employees.
- Authoring and reviewing SOP’s and Methods in Documentum.
- Allowing access to authored SOP and or methods in Documentum.
- Initiation of OOS investigations and Deviations for department via Trackwise.
- Raw Material Testing and training of employees on USP, NF, BP, and EP methods
- Communication with third party vendors for scheduled and random repairs for all instrumentation.
- Testing of GMP and GLP samples and products via GC, HPLC, UV, dissolution and instruments.
- Ordering of both clerical supplies and Laboratory supplies.
- Validation of Junior and Senior Scientists quality data in LIMS.
- Trouble-shooting and Maintenance of HPLC, Transfer modules and Dissolution baths.
- Concentration in Nicotine, Pseudonephrine, and aspirin based products.
- Use of Scientific Journals for research and development purposes