Manager Quality

Bishwanath Sharma

Cell: 908-***-****

Email Id: adgqed@r.postjobfree.com

Personal Summary

●15+ years of Quality & Compliance experience with pharmaceutical,BFS and Insurance clients

●10+ years of experience in Oncology, Supply Chain,Technology services and Consumer Care domain in Pharma Industry.

●Strong understanding of all aspects of Pharma regulatory compliance GxP (Good Manufacturing/Clinical Practices), GAMP, CFR 21 Part 11 and ISO Standards.

●Specialties: Innovation, project and performance management, Cloud & Infra Services validation, process Harmonization, Governance Risk and Compliance & BOT validation.

●Hands-on experience in HP ALM, Service Now & JIRA tools.

●Prior to Cognizant he worked at Capgemini as strategic Business unit Lead. Also led large scale client engagements for Agile validation process setup and successful implementation compliant to regulatory requirements.

●Global working experience: USA, Europe & India.

●Tech Interests: Robotic Process Automation, Mobility and Cloud

Certifications & Trainings

●ITIL V3 Expert

●Professional Scrum Master(PSM1)

●Six Sigma Yellow Belt

●Agile Certified Tester –QAI

●Good Clinical Practice (GCP)-National Institute of Health (NIH), US.

●Attended PMP 35 PDU Training Program.

Feb.2017 –present

Computer System Validation Manager

Cognizant US Tech. Corp.-New Jersey

●Seamless implementation of End to End SaaS, PaaS (Cloud) validation, paperless Digital validation,

data migration /retirement/upgrade and Robotic Automation Framework validation to ensure adherence to regulatory compliance requirements (21 CFR Part 11& European Annex 116).

●Interfacing with Global Quality Directors to chalk out a global Compliance framework for applications to be boarded by the Organization.

●Governance Risk and Compliance (GRC) implementation for a Life Science customer to enable them to move from paper based Risk Management control to Automate Risk Assessment Management.

●Establishing Compliant CSV/CSA processes with Lean, Risk based pragmatic and Nimble (Agile) approach for PHARMA companies.

●Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.

●Responsible for creation of Validation Plan, Test plan & strategy and validation report.

●Hands on experience in Change and Release Management tools such as Service Now.

●Review Change Control requests and assess impact to validation. Support the necessary

Computerized system validation activities for changes.

●Review of all Computer System Life Cycle Documentation: Business Requirements, System/ User Requirements, Design Specifications, Validation Protocols (IQ, OQ, and PQ), pre and post execution review of system and UAT Test scripts Configuration Management Plans, Support Plans, Data Migration Plans and User Documentation (SOPs, User Manuals, and Training Material).

●Creation, review and approval of NCs and CAPAs.

●Support internal, client, and regulatory audits and inspections.

●Assisted business in creating the User/Functional Requirements Specification.

●Assisted technical team in creating Technical Design Specification and Configuration Specification.

●Guided the technical team for data migration and verification activities of migrating legacy data from on premise to Cloud.

●Managing a portfolio of large PHARMA clients.

●Implementing validation-consulting strategy, lead the team of consultants, connect with customers, establish deep customer relationships, and chalk out short term and long-term improvement roadmap.

●This initiative helped to increase the Life Science customer satisfaction by 25% and also products

Launch Time to Market (TTM) was increased by 30%.

●Provide coaching and training to employees, lousiness partners and contractors on computer system validation process and procedures.

●Coordination of Business simulation testing and User Acceptance Testing (UAT) across the geographies, which reduces the UAT test execution cycle completion by 25% and reduction in 20% of test defects.

●Coaching and mentoring the technical teams on Business Driven development (BDD) and Test Management strategy. Mentoring helped to reduce the rework effort by 20%.

●Set up the BOT Service offering for the prospective Life Science customer with a Go to Market strategy, which led to winning a new BOT Validation contract.

●Collaborate with Business Owners/ Technical Application Owners and SMEs on workflow design; provide end-user input drive optimal design of quality systems and adherence to FDA compliance requirements.

●Manages team of managers and professionals within Quality. Hires and mentor employees within the department

Feb.2013 –Jan 2017

Cognizant India Pvt. Ltd. India

Computer System Validation Manager-Life Science Customer

●Responsible for setting up a global quality management office catering to project Quality and Compliance requirements.

●Evaluate business processes and create road map for strategic Robotic Automation initiatives across multiple channels and touchpoints

●Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.

●Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.

●Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements

●Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications

●Defined Release & Change Management Process for a Large Complex MDM Engagement.

●Developed a full set of validation lifecycle procedures and policies including Code Review, Change Control, SOPs, Periodic Review, Decommissioning/Retirement, etc.

●Manage the Large data migration and verification activities of migrating legacy data from on- premise to Cloud.

●Drive the Idea generation session for the Life Science customer and successfully implemented innovations leading to $200k Hard/soft dollar savings.

●Support internal, client, and regulatory audits and inspections.

●Maintain up-to-date knowledge(Knowledgebase) and understanding of quality system requirements as they apply to computerized systems in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.

●Participation in Weekly Governance meetings and providing Senior Management KPIs reporting.

Sep.2012 – Jan.2013

Cognizant India Pvt. Ltd. India

ITIL -Process Manager

●Led the team in setting up an “IT Factory Model” based on ITIL Framework.

●Lead the design, implementation and operation of Change, Configuration, Release and Deployment, Incident, Problem and Request Fulfilment processes for a large Pharma client.

●Support and mentor project team members in the adoption of Service Management best practices.

●Release Management Process Analysis: Map current IT processes via “As Is” and “To Be” Process Mapping and effectively analyse these processes to re-engineer and improve them.

●Defined the KPI in the projects in consultation with diff.Stakeholders.

●Monitoring & reporting of weekly status and KPI reports to clients

●Conduct process reviews, develop process and procedural documentation and provide continual

Process improvement.

●Conduct regular audits on Incident/ Change / Problem processes.

●Analyse and suggest Process improvements to current ITIL processes and procedures.

●Key Person Responsible for Providing Ops.Manual, Remedy Training

Aug.2011- Sept.2012

Cognizant India Pvt. Ltd. India

Corporate Quality (Delivery Excellence) Manager

●Worked on several Service Desk Quality Metrics to improve Performance Preparing Account specific reports for senior management

●Developed ITIL/ITSM Process Flows and Policy Procedure Manuals for Incident, Change, Configuration & Problem Management.

●Performed quality check on Monitoring tickets and Incident tickets and supported the project team in reducing the numbers of recurring incidents and achieving the targeted Customer Satisfaction (CSAT).

●Managed Problem Management queue to address underlying cause for incidents and drive continued improvement in service availability.

●Defined the KPI in the projects in consultation with diff.Stakeholders.

●Monitoring & reporting of weekly status and KPI reports to clients.

●Perform CAPA for any deviations and provide recommendations.

●Designing ITSM Recommendation Plan, Roles & Responsibility, Resourcing, Process Flows, Review Criteria, Report Design document, RACI Matrix, Process Policy document, and checklists.

●Performed Gap analysis of processes and indicative process maturity based upon the capability maturity model (CMMI), i.e. Initiation, Awareness, Control, Integration, and Optimization.

●Maintained knowledge transfer with project team and keeping knowledge management documents updated on SharePoint and circulating periodically to teams

●Helps project in implementing different cognizant processes.

●Process Enablement Sessions conducted for Project team members.

●Streamlined the change management process.

●Service Improvement Initiative in Projects.

Jun.08- Aug.11

Capgemini India Pvt. Ltd. Mumbai, India

Business Unit (Sogeti) - Quality Assurance Lead

●Participation in ISO 9001:2000 re-certification and surveillance audit: Conducted preparedness/ mock audit for the projects

●Participation in ISO 20K Implementation.

●Led the team for AS9100 Certification for Aerospace project

●Provided consultancy to support groups of the organization for their processes and process improvement viz. Procurement, Training.

●Agile Metrics implementation for one of US Clients.

●Drive the complete process definition phase right from QMS structure to conceptualization and so on

●QMS gap analysis against a given model or set of Process Areas

●Study and analyse the existing set of quality systems and processes and develop new processes and systems to achieve the desired capability model

●Review of process change or Process Improvement suggestions

●Assist / participate in the pre assessments as required by the organization.

●Building Policy and Process around the Metrics for the Organization

●Facilitating process implementation using Standard Process tailoring

●Assist in developing and enhancing the QMS and Process Documentation in close coordination with the SEPG

●Doing Risk Analysis of a Project using FMEA and RAT Tool.

●SQA reviews, IQA audits, special Process area focused audit for multiple project types and functions (DP, SQA, Metrics team and so on)

●Conducting Internal Audit of Projects.

Aug.06-Jun.08

Citi Technology Services Ltd(Citigroup ), Mumbai, India

Sr.Software Specialist

●Working on Product Development Life Cycle.

●Continuity of Business (COB) Process for different business units.

●QM Activity (SDLC Projects review).

●Handled a team for Process Definition.

●Conducting Process & Internal Audit in the Organization.

●Involved in Implementing the Process areas in Projects and Organization.

●Collecting Metrics from Project Teams and consolidating

●Training Project team members on project defined process

●Coordinating with Client for Closure of NCR's and carryout Gap Analysis.

●Imparting Training to Engineers on Product Development Life Cycles and COB.

●Conducting Internal Audit of CoB.

●Conducting Process Compliance Audits for Projects in the Organization.

●Fully familiar with QC tools for Metrics Trend Analysis and Statistical process Control.

June 05 – Aug. 06

Unikaihatsu Software Pvt. Ltd. Goregaon, Mumbai, India

Management representative

●Checking for compliance by conducting Software Quality Audits.

●Responsibilities include managing multiple projects, SQA Review of projects, resource utilization.

●Working on VSS.

●Performing Quality Assurance (QA) activities for projects.

●Facilitate Metrics data collection & analysis; perform causal analysis and defect prevention activities.

●Conducting Process Training, Brainstorming session

●Conducting Process & Internal Audit.

●Ensure compliance to standards in project delivery to Client.

●Successfully completed Surveillance Audit by BSi (May 2006).

Sept. 02 – Jun. 05

Britex Engineering Works, Mumbai

An ISO 9001:2000 Manufacturing company

QA/QC Engineer

●Prepare QAP, inspect Equipment /Material To Prepare inspection dossier as per ISO norms.

●Manage the Quality Related expectations, requirements of the co./customers as well as prospects and minimizing the non-conformity of products.

●Preparation of GRIN for trace ability of the products.

●Implementing, Managing Compliance monitoring quality assurance methods & procedures.

●Coordination with inspection agency viz. EIL, Toyo, Jacob H&G, KPG, Bureau Veritas, NPCIL, BARC, DNV, IRS, TCE familiar with their inspection activities.

●Knowledge of diff.stds. & Codes, ASTM/ ASME SEC.II, SEC.VIII, SEC IX, API590, ANSI B16.5&their applications.

●Hand on experience in Heat Treatment of Alloy Steel, Carbon Steel Vs Stainless Steel.

Achievements and Extracurricular activities:

●RAVE Award (Star of Quarter) for Exceptional Customer Service by reducing the turnaround time.

●Key team member for AS9100 Certification for Aerospace project in Capgemini.

●Delivery Excellence Awards(NA) for exemplary customer delight and continuous improvement initiatives in subsequent releases.

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