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It Validation Lead Resume

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Somerset, NJ

SUMMARY:

  • I have over 15 years of validation experience all within a Quality and GMP environment. I am an expert in Quality Systems and love working in a regulated environment aiming for exceeding expectations at all times. I am very knowledgeable in the change management process and understand it is critical in executing tasks in a timely manner.
  • I am an expert in computer Systems Validation with a specialty in automated systems such as various QMS, ERP, SAP, Trackwise, EMPOWER, Kaye Lab Watch (Environmental Monitoring system) and BMS. I have worked with companies under FDA 483 and always met deadlines.
  • I have the ability to use risk based validation to achieve desired results saving companies time and ultimately money.
  • I can work with client to setup methods and setup user rights administration.
  • I can create SOPS for usage and/or maintenance and coordinate with IT Validation to ensure that all deliverables across the product lifecycle (SDLC), ranging from requirements documentation (URS), high level/detailed design, and code deliverables to packaged solutions for release, are created and approved.
  • I am also an extraordinary Global trainer on IT/Quality processes and systems.
  • Expert in 21 CFR Part 11
  • GAMP 5
  • Validation extraordinaire
  • Virtual (Remote)Validations expert
  • ERP Validation and Implementation
  • User rights Administration for QMS, MES and SCADA
  • User right and Administrator for ERP systems, SAP, BMS and Kaye Lab Watch System
  • HP - ALM; HPQC testing tool
  • Protocol writing, technical operations, Computer system validation testing, change control summary reports, CAPA, deviations, internal audit plans and final reports.
  • Technical Subject Matter Expert: All Process Manufacturing Operations, systems and tools, cGMP, OJT, s program (Train the Trainer).
  • Utilizing ERP, TrackWise as well as SAP to document Audits, CAPA’s, and Change
  • Root Cause Analysis (RCI) Program development and implementation.
  • Change Agent
  • Technical writing SOPs, Doc. Retention, Archival, Backup, Business Continuity and Batch review.
  • Interdepartmental relationship building/team building
  • GMP & E-learning Development using the LMS method and such software, Microsoft PowerPoint, Sharepoint and various Learning Management Systems.
  • CFR (11, 210, 211, 820)
  • ISO 9001 & 13485
  • Systems experience include various ERP systems, MES, BMS and SCADA, ERP systems, EMPOWER2 & 3, Confidential, Millenium, TrackWise,, NextDocs, SAP LEM, SAP Solution Manager, LIMS, Waters CDAS, A+

PROFESSIONAL EXPERIENCE:

Confidential, Somerset, NJ

IT Validation Lead

Responsibilities:

  • Facilitate the Computer System Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
  • Defined User Specifications and Design/Functional Specifications
  • Responsible for the creation, management and approval of computer system (BAS, I-Vu) validation process and documentation(IQ, OQ, PQ) to ensure compliance with CFR 21 Part 11 for all regulated systems. This specifically includes managing standard operating procedures for application management,, and review of project documentation to ensure compliance
  • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members
  • Ability to develop all documentation required for a 21/11 validated project, including Validation Plans and Final Summaries/Reports
  • Provided detailed on the upkeep of application and maintaining computer system in a validated state (Periodic re-evaluation, change management, etc.)

Confidential, Belleville, NJ

IT Validation Lead

Responsibilities:

  • Ensured the Software (A+) is verified and validated against the criteria set out in the functional and non-functional specifications, by defining test cases and ensuring their execution.
  • Utilized “Virtual” (Remote) Validation
  • Specified requirements for environment, d Confidential, resources, and tools.
  • Responsible for the complete Validation of a legacy ERP(A+) system including Gap/Risk Assessment, URS/FRS, Configuration Documentation, IQ, OQ, PQ protocols, Execution, and final report.
  • Coordinated tasks for project management to utilize entire team to get job done in record breaking timeframe
  • Reviewed/Revised IT SOPs to update to current 21 CFR Part 11 standards
  • Actively provides feedback to senior QA management which resulted in new working practices or general QA improvements for QMS.
  • Generated an ERP system (A+) management SOP and Change Control SOP to keep newly validated system in a validated state.
  • Provided detailed analysis of all testing carried out on the environment ensuring all bugs, risks and issues are logged correctly.
  • Worked with high level management and support staff to Implement and validate ERP system to ensure continued customer satisfaction
  • Coordinated Business Continuity Plans with IT team
  • Maintained close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

Confidential, Belleville, NJ

Senior Manager, Computer System Validation

Responsibilities:

  • Responsible for the Validation Master Plan and all SOPs(new QMS)
  • QMS Implementation for Medical Device
  • Team lead for 10+ consultants on multiple global projects
  • Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure systems to be developed adhere to corporate SDLC methodology.
  • Drive understanding and adoption of Quality and Compliance standards.
  • Remediation and Risk Expert of GxP IT compliance
  • Ensure Quality & Compliance requirements are considered in any initiative or major change request.
  • Expert Trainer to all departments with hands on as well as computer based
  • Ensure the compliance deliverables are updated and kept current with all applicable changes.
  • Work with IT and business teams within Medical Device clients to drive/maintain/create Quality program.
  • Aligns the development methodology with Compliance plans, policies and procedures.
  • Effectively manage ongoing change control process (interface to IT support, impact analysis, release management, d Confidential changes, testing etc.).
  • Facilitate ‘Virtual Validation” initiative to support industry in “remote” computer systems upkeep and validation to keep all legacy units in compliance with current regulations
  • Responsible for developing Workshops and Management modules for customers saving money and time.

Confidential, Suffern, NY

Quality Systems Team Lead

Responsibilities:

  • An “Excellence” type of environment that can assist with almost any question in the realm of computer validation, Part 11, and computer system testing
  • Validation of computer systems in GMP environment
  • A customized approach to meet individual client requirements
  • Draft validation deliverables / test plans and test cases, based on system understanding and analysis of functional and system specifications.
  • Clear, well-organized, and defensible SOPs, validation reports, testing reports and other documentation to meet the most stringent regulatory requirements
  • Maintained quality system processes (QMS) in compliance with GMP/ISO quality standards.
  • Led team of 9 to assess and revalidate/remediate quality systems under FDA 483 citation
  • GAP remediation for Legacy Computer Systems(QMS, SAP, ERP)
  • Installation, Qualification, and Implementation of numerous automated Quality systems
  • Partnered with all departments to analyze, design, develop, implement, evaluate and strategically build robust, working with area Subject Matter Experts (SME’s) to develop and implement sustainable compliance in each department.-
  • Supported team to convert physical methods to automated, electronic methods
  • Formulated procedures, specifications, and standards for products and processes
  • Provided leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
  • Developed and implemented corrective/preventative action plans
  • Serving on the Deviation team: Assisting with Deviation closure, coaching on deviation writing and finding root cause using RCA tools such as 6Ms and 5whys. Quality System used SAP for Deviation, Trackwise for Change Control.
  • Collected and analyzed d Confidential for gauge and product evaluation. Identify critical personnel, gauges, procedures, and materials needed for the completion of new products
  • Reviewed and Approved test scripts and reports for Quality Systems
  • Worked within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, vendors, etc.).Facilitates team efforts on quality validation projects.
  • Delivered, met all deadlines ahead of schedule.
  • Communicated both orally and in written form to multiple levels of the company
  • Utilized statistics (Mini Tab), process control, and process capability as needed.
  • ERP assessment, remediation, and implementation()
  • SCADA and MES upgrades
  • BMS transfer from Suffern to East Hanover, validation paperwork and change management

Confidential, Suffern, NY

Quality Control Laboratory Systems Specialist

Responsibilities:

  • Lab Relocation (equipment purchasing and SOP creation and execution)
  • HP-ALM utilized to upgrade computer systems post relocation
  • Responsible for a variety of tasks related to laboratory instrumentation/equipment, as managing and overlooking equipment change requests in a timely manner, for preparing the life cycle documents of laboratory equipment (GC/ Spectrophotometers/ HPLC hardware and Software (SDLC))
  • Supported the local system owners of the QC laboratories in defining the user requirements and needs for SAP and LIMS. Also contacted vendors when needed and coordinates their activities.
  • ICE trained and cGMP trained and certified. Expert on 21 CFR Part 11.
  • “Train the Trainer” certified
  • Responsible for the preparation and execution of equipment (HPLC/GC) binders containing technical & qualification Novartis life cycle documents & required vendor documents, IQ/OQ/PQ Protocols, and Summary Reports.
  • Perform periodic and/or time driven re-evaluation/ requalification assessments, change control requests and decommissioning/ retirement activities as applicable, and revision of associated life cycle documents reflecting these activities.
  • Facilitates instrumentation (HPLC/GC (hardware) and ChemStation (software) qualification with external vendors, internal and/or external resources and local system owners.
  • Conducts field execution of various protocols, IQ/OQ/PQ.
  • Ensure compliance to cGMP, regulatory regulations and Novartis global and local policy for laboratory equipment.
  • Develop and Review the appropriate SOPS and corresponding Forms
  • Preformed and supported Quality Audits to ensure compliance to quality system requirements and to identify appropriate CAPA activity.
  • Supported and tracked investigations and resolutions of audit findings
  • Re-audited processes and associated procedures/records to verify effectiveness of actions where applicable.
  • Maintained audit documentation and records.
  • Supported corporate audits and external agency audits including FDA and other certifying bodies, government agencies, alliance partners and consultants, as necessary.
  • Assisted in the development of new work instructions and .
  • Used my knowledge of Quality systems to support all applicable requirements
  • Strong written and verbal communication and interpersonal skills
  • Worked on several cross-functional teams.
  • Proficient computer skills include: electronic mail, project management, record keeping, and routine d Confidential base activity, word processing, spreadsheet, graphics, etc.

Confidential, North Brunswick, NJ

Computer Systems Validation Specialist

Responsibilities:

  • Responsible for the installation qualification, preventive maintenance, operational qualification, performance qualification, troubleshooting and innovation of over 20 instruments that are commonly used in the pharmaceutical sector such as HPLC, GC, UV spectrophotometer, dissolution baths, auto samplers, disintegration testers, and fiber optic UV spectrophotometers.
  • Performed software validations on SAP, Trackwise, Agilent ChemStation, and LeapTec Opt Diss. Also interfaced SAP with Laboratory Computerized Systems.
  • Experience with LIMS, Electronic Lab Notebooks, Sample Management Systems. Performed customer and provided extraordinary customer service and leadership in the field. Also a team leader and repair specialist on the site. Maintained company vehicle and calibrated company validation tools such as calipers, digital volt meter, thermometers, etc.
  • Responsible for the NJ, CT, NY, DE, PA, and MD area.

Confidential, Mahwah, NJ

Laboratory Quality Systems Administrator/Scientist

Responsibilities:

  • Responsible for the daily calibration of all laboratory instrumentation.
  • Also responsible for New York UV Disinfection validation of drinking water.
  • Collected samples in the field and analyzed samples using laboratory equipment such as HPLC and UV spectrophotometer.
  • Responsible for computer systems management such as SAP, BMS and LIMS.
  • Evaluated procedural document (SOPs and calibration procedures), including the creation of the On-the-Job (OJT) Checklists and Performance Checklists
  • Collaborate with Document Authors and Functional Area Management to determine target learning levels (awareness, comprehension, and application), target audience, delivery methods, and assessment methods (including the development of assessment questions).
  • Assisted in the development of materials with Subject Matter Experts and Functional Area Management
  • Provided guidance on development to Document Authors and Functional Area Management
  • Ensure materials are approved prior to use.

Confidential, Maplewood, NJ

Test Engineer

Responsibilities:

  • Served as the technical trouble shooter for the system for all internal employees via online or offline.
  • Responsible for analyzing NJPDES samples, wastewater and soil samples. Also responsible for collecting samples at generating stations for further analysis in the lab such as pH, conductivity, titration, etc.
  • Utilized the UV spectrophotometer, ICP, FTIR, and AA.
  • Assisted in the calibration of these analytical instruments. Calibrated analytical balances daily and maintained instrument logbooks.

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