INFORMATION GOVERNANCE MANAGEMENT (IGM) MANAGER / SR. QUALITY MANAGER
Seeking a senior position in IT Validation, Quality and Compliance which utilizes my technical and organizational skills in a developing and challenging environment. Accomplished CSV IT QA professional with 9+ years of progressive experience and proven record of significant, successful contribution in Computer System Validation (CSV), Quality Management, Project Management, Process Improvement, SDLC, Standards and Systems in a wide range of regulated (GxP) organizations. Lead team of internal employees and external 3rd party resources for global GxP projects. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements. Self-motivated, highly organized with superior leadership qualities. Managed CSV activities for medium to large complex projects for multiple sites globally. Ability to interact across all levels of the IT organization along with demonstrated success in a "matrix" type environment. Responsible to work with senior management and line function heads to define road map for projects within the GxP Organization. Manage and advise on critical GxP compliance and quality issues. Work closely with Quality Assurance team to ensure the GxP systems are in compliant with Regulatory Requirements. Plan and manage GxP projects; prepare and maintain accurate records; analyze; manage budget and cost control. Responsible for providing GxP and CSV training to IT Organization within regulated industries. In-depth knowledge of Validation, Quality Management, Quality Assurance, Documentation, Equipment Validation, Facilities, SIP, CIP, Vendor Auditing and Product Improvement. Responsible to build full Validation life cycle experience including developing and maintaining Validation Plans (VPs), Validation Scripts, and preparing Validation Summary Reports. Responsible to create SOPs, WIs, Operations Manual within regulated environments for GxP systems in order to maintain systems in validated state. Responsible for auditing CSV deliverables and assist QA during the FDA audits. Responsible for the validation of IT-Shop Floor applications, Infrastructure Systems & Quality systems like Application Server, Enterprise Backup Server and Cognos reporting System in both GMP and GLP environments. Lead all IT Infrastructure Qualification projects including Databases, Network Operations, Middleware, Storage & Backup Services and provide support to AWS cloud qualification. Experienced in validating custom built applications and COTS systems. Experienced in documenting all phases of system life cycle as required by FDA regulations. Track record for providing definitive compliance technical expertise for Manufacturing, Lab and Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21 CFR Part 11/Annex11. Create and execute validation plans to document all phases of the system life cycle as required by FDA regulations and GxP documentation standards for finished pharmaceuticals. Developed and implemented successful corporate programs (including authoring quality documentation) to improve quality control and quality assurance throughout Software Development Life Cycle (SDLC). Manage Change Control Requests and provide assistance in the execution of changes for GxP systems. Health Authority Regulations: Food and Drug Administration (FDA) regulations: FDA 21 CFR Part 11: Electronic Records; Electronic Signatures; Final Rule; August 20th, 1997, Part 210 (cGMP in manufacturing, processing, packaging and holding of goods), Part 211 (cGMP for Finished Pharmaceuticals), Part 810 (Medical Device Revise Authority), and Part 820 (Quality System Regulation) Swiss Medic: Swiss Ordinance relating to Good Laboratory Practice (GLP), adopted May 18th, 2005 [RS 813.112.1]. This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97) 186/Final]. Experience in cGxP environments like cGMP, cGAMP, GCP, cGLP, and developing MVP, VPs, IQ, OQ, PQ, URS, FRS, TM, VSR and SOPs. Good skills in Computer System Validation (CSV). Excellent written and verbal communication skills. Ability to work individually or as a part of a team. Experienced as team resource and individual contributor. Perform other duties as assigned.
Examined QSAR statistical models to analyze/elucidate the relationships between structure and activity of biologically active compounds.
Investigated the receptor-ligand docking models using Computer assisted-drug design (CADD) techniques.
Developed Pharmacokinetic models of anti-HIV-1 protease inhibitors using in silico methods to understand the bioavailability of drug molecules.
Responsible for creating Pharmacodynamic models of C2 symmetric HIV-1 protease inhibitors and analyzed drug-receptor interactions.
Developed a database of C2 symmetric HIV-1 protease inhibitor molecules (~400 molecules).
Novartis Institutes for BioMedical Research (NIBR) Cambridge US/ Basel SwitzerlandInformation Governance Management (IGM) Manager / Sr. Quality Manager12/2012 to 04/2016
Managing the global NIBR Informatics (NX) Organization in regulatory compliance and Quality Management, focusing on the GxP areas.
Responsible to lead all CSV projects for GxP systems within IT Organization and act as both Project QM and Operational QM.
Responsible for the assessment, facilitation and verification of quality standards achieved within IT activity in a designated geographic/operational area in accordance with the requirements of Novartis corporately and any external legislative and regulatory requirements (GxP).
Responsible to apply the specifications of the corporate and organizational Quality Systems and Quality standards to ensure that the quality of processes and deliverables of both projects and services continuously meet their specified corporate and regulatory requirements.
Lead NX Quality Management in operating the NX Quality System Navigator (NQSN) and support the continuous improvement process for the system.
Managing the iLearn (LMS) for NX and responsible to assess training requirements for global NX organization.
Together with all NX teams assure compliant operation and establishment of IT Application systems.
Responsible to deliver CSV and GxP training to the IT Personnel as part of the onboarding procedures.
Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements.
Supports ongoing change management for GLP systems in conjunction with the IT Business Partner and GLP system owners as required by company procedures.
Reviews and approves change requests based on risk / business need.
Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course.
Drive shifting of emphasis from "final inspections" to "in-process reviews and controls".
Contribute to business decisions in the definition and assessment of IT requirements.
Responsible for the development and delivery of training in quality matters.
Drive and facilitate the creation of relevant SOPs.
Interface with business and IT partners to ensure Novartis practices are aligned with regulatory expectations and industry best practices.
Prepare and follow internal and external authority inspections.
Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
Coordinates documentation, testing, and change management activities to ensure compliance with business and regulatory needs.
Partnering with Quality Assurance departments in order to align quality related processes and to achieve common agreement on standards Manage projects in collaboration with Information Security and Cyber Security teams.
Vensai Technologies Inc PfizerCumming, GASenior CSV Lead12/2007 to 12/2012
Responsibilities: Supported the Global IT teams in providing guidance and support in all areas of QM (IT Quality Management) to adhere compliance to Internal (ITIC) and External (eg.GLP) requirements framework.
Supported the Global IT teams in maintaining the systems status conform to internal and external requirements (Operational QM) Provided and supported in establishing process documentation e.g.
creating and maintaining work procedures for IT service operations Involved in defining the User Access Management process for both GxP and Non-GxP IT Infrastructure systems Developed Operations Manual and SOPS for IT Infrastructure systems at NIBR IT.
Responsible for approving executed Installation Qualification (IQ) protocols for all IT Infrastructure systems Supported DMZ Network Infrastructure Qualification as Project Quality Manager for USCA, USEM and CNZJ sites Responsible for developing Remediation Report for LAN project and ensured that all the observations stated in the Remediation Action Plan are addressed accordingly Involved in validating COTS (Commercial off the shelf system) -Warehouse Management System (WMS).
Wrote the Validation Test plan according to IEEE standards, which are in conjunction with FDA regulations.
Created Qualification documents like Installation Qualification /Operational Qualification (IQOQ) and Installation Qualification /Performance Qualification (IQPQ).
Assured that all validation documentation such as IQs, OQs and PQs are in compliance with cGMP's.
Create and execute validation plans to document all phases of the system life cycle as required by FDA regulations and GMP documentation standards for finished pharmaceuticals.
Checked whether the executions of the e-signs are audit trailed.
Responsible for developing Validation Testing protocols and Acceptance Testing protocols.
Responsible for writing User guides and Training materials for the end users.
Created Equipment Specification and Preventive Maintenance Specification documents for automated systems.
Worked with a SOP committee to develop the language and details for all Software and Hardware SOP's.
Responsible for creating Project Validation Plans for various custom built IT-Shop Floor applications for Kalamazoo, MI and Lincoln, NE Manufacturing Facilities.
Interacted with the end users to understand business requirements & define requirements specifications.
Coordinated with Business Analyst and Developers to generate Story Board.
The Story Board was generated using Microsoft Visio to provide a visual workflow.
Responsible for creating Assessment documents like System Impact Assessment (SIA), Component Impact Assessment (CIA) and Electronic Record and Electronic Signature (ERES) 21 CFR Part 11 Compliance Assessment.
Developed Specification documents like User Requirement Specification (URS), Functional Specification (FS) and Design Specification (DS).
Introduced Use-cases and Use-case diagrams in the Functional Specification document.
Implemented innovative ideas for the Design Specification document by introducing UML diagrams like Activity diagrams, State diagrams, Class Diagrams, Sequence diagrams and Interface diagrams using Microsoft Visio.
Involved in documenting the Detail Design Specification (DDS) document.
Developed the validation protocols for FDA standard testing plan/design documentation for all Shop Floor applications.
Created and executed Qualification documents like Installation Qualification /Operational Qualification (IQOQ) in the Validation environment and Installation Qualification /Performance Qualification (IQPQ) in the Production environment.
Performed Unit/Integration Testing (UIT) and User Acceptance Testing (UAT) in the Development environment.
Responsible for writing User guides and Training materials for the end users.
Developed Data Migration Plan/Report for various projects.
Involved in maintaining Requirement Traceability Matrix (RTM).
Attended project meetings to discuss about the project progress.
Created Project Commissioning and Qualification Report (PCQR) or Final Report to summarize the completion of all commissioning and qualification deliverables and activities outlined in the Project Commissioning and Qualification Plan (PCQP).
Clarkson UniversityJob Type: Teaching Assistant- General Chemistry-II08/2006 to 12/2007
Responsible for teaching undergraduates General Chemistry.
Conducted General Chemistry labs for Undergraduates and graded pre & post labs worksheets.
Conducted weekly assignments and also graded them.
Clarkson UniversityJob Type Research Assistant08/2005 to 07/2006
Responsible for creating Linear and non-linear QSAR models to study peptidic HIV protease inhibitors.
Masters:ChemistryClarkson University, NYChemistry
Bachelor of PharmacyRajiv Gandhi University of Health Science, Bangalore, India
Quantitative Structure Activity Relationship (QSAR) studies of Anti-HIV-1 ritonavir analogues. Raghava C. Kasara, Barun Bhhatarai and Rajni Garg, 232nd American Chemical Society National Meeting San Francisco, CA, September 10-14, 2006.
*Pharmacokinetic modeling of anti-HIV protease ritonavir analogues. Raghava C. Kasara, Barun Bhhatarai and Rajni Garg, 233rd American Chemical Society National Meeting Chicago, IL, March 25-29, 2007.
*Pharmacodynamic modeling of C2 symmetric HIV-1 protease inhibitors. Raghava C. Kasara and Rajni Garg, 234th American Chemical Society National Meeting Boston, MA, August 19-23 2007.
21 CFR Part 11, Business Analyst, change management, Chemistry, Hardware, continuous improvement, DDS, Data Migration, delivery, documentation, Functional, GMP, GLP, Information Security, IQ, LAN, regulatory compliance, Managing, meetings, Access, Microsoft Visio, Navigator, Network, organizational, Personnel, processes, progress, protocols, Quality, Quality Management, Quality Assurance, Requirement, SOP, Specification, system documentation, teaching, Training materials, UML, Validation, workflow
AWARDS, HONORS & ACTIVITIES: NIBR Recognition Globally Spotlight Award for Improvise & reduce bureaucracy and Strategic thought. Active Participation in Novartis Community Partnership Day (CPD) 2013, 2014, 2015 Pfizer IT Excellence Award for IT shop floor system projects ACS CINF-FIZ Chemie Scholarship Award for scientific excellence Fall 2007 ACS CINF-MDL Elsevier Scholarship Award for scientific excellence Spring 2007 Gold medal in inter-high school Quiz competition Clarkson Intramural volleyball champions
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Companies Worked For:
Novartis Institutes for BioMedical Research (NIBR) Cambridge US/ Basel Switzerland
Vensai Technologies Inc Pfizer
Rajiv Gandhi University of Health Science
Job Titles Held:
Information Governance Management (IGM) Manager / Sr. Quality Manager
Senior CSV Lead
Job Type: Teaching Assistant- General Chemistry-II
Job Type Research Assistant
Masters : Chemistry Bachelor of Pharmacy
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