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Summary

an it- quality professional with extensive experience in Software Quality Assurance, Software Testing, computerized system Validation (csv) of GXP systems and Medical Devices Applications.

Experiences

Past Experience

  • Associate Manager Pune, Maharashtra, India

    July 2015 --- April 2016

    end-to-end Validation

    -           Planning Validation activities for upgrades / new releases of GXP-critical Applications, e.g. learning management system, Clinical study designing systems, complaint management system, ipad based Applications.

    -           developing Validation Documentation for Validation projects; Validation plans & summary reports, user & functional requirements, traceability matrices, risk assessments, installation / operational / performance Qualification documents (iq/oq/pq)

    -           facilitate & review test scripts development and provide Compliance assistance during test executions

     

    itqa office

    a reputed pharma company has outsourced its it quality office to accenture. as a lead to a small team of 4 people comprising this itqa office, below are my responsibilities:

    -           reviewing and approving Qualification plans and reports for business

    -           assisting business to develop Documentation such as requirement updates

    -           Change Control: ensuring that appropriate Change Control process is followed, reviewing and approving cr cases pre and post implementation of change

    -           reviewing and approving deviation reports (remarks and non-conformities), including capa and Root Cause Analysis

    -           ensuring the Compliance of deliverables with good Documentation practices

    -           assisting business in document archival

     

    Quality Management in associated business Operations teams

    -           ensuring establishment of quality processes in other service areas of project

    -           developing audit checklists for Operations

    -           performing quality audits for the established processes

    -           providing quality consultation to the Operations teams

    -           standardizing the Validation deliverables

  • Assistant Manager Pune, Maharashtra, India

    January 2015 --- July 2015

    Quality Management in service transitions

    -           perform transition audits; initiate & prepare, go-live

    -           review and approve transition deliverables: specifications, slas, kpis, sops and other Documentation

    Quality Management in business Operations

    -           developing audit checklists for new Operations

    -           performing quality audits for ITIL process Compliance

    -           identifying non-conformities, performing Root Cause Analysis and capa

    -           providing quality consultation to the operational teams

    continuous improvement

    -           working as a quality representative for ci; analyzing and approving new ideas

    -           performing quality reviews and facilitating implementation

  • Compliance Consultant Pune, Maharashtra, India

    January 2012 --- September 2014

    responsibilities:

     

    • developing deliverables for Validation status maintenance of GXP critical systems: periodic review reports for user and user accesses Accounting, configuration status Accounting
    • performing quality reviews for periodic review reports prepared by vendor / other internal parties, for content, Compliance and good Documentation practice
    • preparing annual Validation status summary reports for GXP critical systems
    • participating in development of new Compliance service/s: configuration management
    • interacting with it quality representatives in order to close the gaps in periodic review report results and obtaining approvals from itqa through review cycles.
    • developing internal quality tools, templates
    • if and when needed, provide sme inputs to business

  • Senior Associate Pune, Maharashtra, India

    August 2011 --- January 2012

    responsibilities:

  • Business Analyst Bangalore, Karnataka, India

    October 2010 --- July 2011

    responsibilities:

    • handling various periodical reports related to user management, configuration management and Validation status summary.
    • performing quality reviews for periodic reports prepared by vendor / other internal parties, for content, Compliance and good Documentation practice
    • interacting with it quality representatives in order to close the gaps in periodic review report results and obtaining approvals from itqa through review cycles.

     

    key achievements: standardized the procedure for annual user reviews for all GXP-critical it systems: user review process used to be system-specific for all the systems. we standardized the process in the generic manner for all the system, keeping some margin for system-specific activities. this resulted in significant reduction in effort for annual user review activity.

  • Application Specialist Pune, Maharashtra, India

    February 2007 --- October 2010

    project: csv activities

    client: reputed Pharmaceutical companies and laboratories

    responsibilities:

    • conducting gap Analysis for clients qms with respect to Regulatory Compliance
    • developing and implementing csv policies and procedures
    • provide technical expertise, resource and support for the implementation, Computer System Validation (csv) and ongoing maintenance activities related to it systems
    • developing quality plans
    • developing iq/ oq/ pq plans and reports

     

    project: dual polarized interferometry Software - Software Quality Assurance

    client: a reputed british company

    responsibilities:

    • worked as sme for development of 21 cfr part11 compliant application
    • qa lead: designed and carried out qa activities
    • Life Sciences sme: providing domain support throughout sdlc

     

    project: Medical Imaging Software - Software Quality Assurance

    client: a reputed canadian company

    responsibilities:

     

    project: Software for mass spectroscopic Analysis

    client: reputed american companies

    responsibilities:

  • Research Assistant Pune, Maharashtra, India

    July 2001 --- July 2006

    responsibilities:

    • designing, Planning and executing scientific experiments required for the respective project
    • managing Laboratory activities in the capacity of senior Research Assistant.
    • writing projects for government funding agencies in india, dbt, dst.
    • writing and publishing research papers, presenting the research works in scientific conferences.
    • gaining expertise in new molecular biology techniques and implementing in the Laboratory, sharing knowledge with colleagues.

     

    • Life Sciences sme
      • worked as a senior Research Assistant assessing the effects of high salinity on developmental Gene expression in amphibian embryos
      • worked on assessing the role of pre-vitelline fluid of horseshoe crab in promoting heart development in chick embryos
      • worked on finding vertebrate homologues in hydra vulgaris

     

    associated projects:

    center for dna fingerprinting and Diagnostics, hyderabad, india

     

    bangalore genei pvt. ltd., bangalore, india

    • worked on isolation and Purification of restriction endonucleases from various Bacteria
    • achievements:

      • published a research paper in current sciences, reference: 568, 90  no. 4, 2006
      • published a research paper in indian journal of experimental biology
      • received dst funding for a project

Personality

Self Assessment :
AdaptabilityAttention to detailCommunicativeCoordinationCreative thinkingDependabilityProactivityCollaboration

Knowledge

Self Assessment :
Medical devices21 CFR Part 11Adverse Events (AE)ApplicationsAuditingBusiness ProcessesCAPACDISCcGMPChange ControlChange ManagementComplianceCompliance with regulationsGood Clinical Practice (GCP)Good Distribution Practice (GDP)Good Laboratory Practice (GLP)Good Manufacturing Practice (GMP)Healthcare Information TechnologyICH guidelinesLife SciencesMicrosoft PowerpointMicrosoft WordMicrosoft ExcelPharmacovigilanceQA complianceQualificationQuality Assurance (QA)Quality Control (QC)Regulatory ComplianceRoot Cause Analysis (RCA)Software DocumentationVerificationWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Create SOPs Use content management systemsAdjust processes and methodsAssess quality process issuesAssist with proceduresAttend at steering committee meetingsCreate standard operating procedure (SOP)Creates a collaborative team environmentData validationData verificationDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesDevelop regulatory strategyDevelop training materialsEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsIdentify risksLiaise with professionals in other divisions of the company as requiredManage global quality standardsManage laboratory proceduresManage Quality Management System (QMS) documentationPrepare internal auditsPrepare regulatory documentsProvide benefit risk assessmentRegulatory documentationWrite documentsWriting regulatory documents

Education

  • Master in Zoological Sciences from Pune University, Pune, India in 2001

Training and Certification

  • ITIL V3 Foundation in 2010 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Hindi
Native
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Quality Assurance (QA) Manager Quality manager Quality
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl freelancer :    40 Hours per week
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Munich, Germany

Others

Driving License
  • No

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