Computer System Validation Consultant/AM

1 day ago


Pune, Maharashtra, India Talworx Solutions Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  • Support on IT quality systems framework design and implementation
  • Managing the reviews and assessments for IT quality
  • Assist in Computer System Validation (CSV) compliance of GxP processes for

pharmaceutical companies or experience on quality compliance services for global consumer

health care, medical devices, and pharmaceutical companies

  • GxP Business process review
  • Development of integrated GxP and IT compliance
  • Standard operating procedures and guidelines
  • GxP and IT compliance assessment
  • Define the Validation strategy of IT Software and Systems
  • Actively participate in the Validation Life Cycle of regulated IT projects or platforms by

planning validation deliverables, working on validation documentation, participating in

authoring deliverables, functional requirements definition, traceability matrix, validation

protocol development,

  • Validation testing and deviation management; and working closely with cross-functional

project teams.

  • Ensure 21 CFR Part 11 compliance for Computerized system
  • Provide User training on CSV and increase awareness about compliance
  • Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new

computerized systems and providing a remedial action plan for compliance.

  • Carrying out an Audit of IT systems to ensure regulatory compliance
  • Manage the specified business/systems requirements, working closely with the designated

Project Manager to facilitate the progress of the project Coach/mentor staff and provide

technical leadership, as needed

Preferred candidate profile

  • IT Quality, Regulatory, Compliance (IT-QRC)
  • Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies
  • GxP practices and GAMP5 guidelines.
  • Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and

other related applications used in pharmaceutical industries

  • Experience in activities like Business Analysis, Risk Identification, FRS creation and other

validation testing deliverables.

  • Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations.

Qualification

  • • B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharm or similar
  • • Experience range 2 years to 8 years


  • Pune, Maharashtra, India Infosys Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    CSV ConsultantHands-on experience on testing tools like HP ALM, Kneat and SNOW - Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage - OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) - PAS/DCS Qualification - ISA95 High level of...


  • Pune, Maharashtra, India LTIMindtree Full time

    Computer System Validation-Experience: 6 to 12 YearsLocation:- PAN IndiaNotice period : Immediate to 15daysShift : 2:30PM - 11:30PMInterested candidate can share the cv at ranjana.singh1@ltimindtree.com Mandatory Skills : Regulatory & Compliance - Computer system validation, Regulatory & Compliance - Process Quality Assurance.Role Summary:Computer system...

  • AMS Solution

    7 days ago


    Pune, Maharashtra, India Capgemini Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Experience Required:6+ years*Your Role*Job Summary:We are seeking a dynamic AMS Solution Presales Consultant to lead end-to-end solutioning, bid management, and proposal development for global AMS pursuits. The ideal candidate will have strong technical writing skills, presales experience, and a passion for solution selling.Key Responsibilities:Design AMS...


  • Pune, Maharashtra, India E Tech Group Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    At E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing &...


  • Pune, Maharashtra, India AM Infoweb Full time ₹ 1,50,000 - ₹ 2,00,000 per year

    AM INFOWEBAct as a mediator between insurance company's/law firms and hospitals, doctors, clinics medical facilities. Do a follow-up on medical reports of patients who have been discharged from the mentioned medical institutes.The main aim is to get the medical facility reports within the time frame mentioned by the client.Key Responsibilities:Handle inbound...


  • Pune, Maharashtra, India AM Infoweb Full time ₹ 1,04,000 - ₹ 2,10,000 per year

    Role & responsibilitiesKey Responsibilities:Handle inbound and outbound calls to medical facilities, doctors' offices, and other healthcare providers to retrieve medical records.Navigate through medical records systems efficiently to locate and retrieve requested information. Verify the accuracy and completeness of medical records retrieved, ensuring...


  • Pune, Maharashtra, India AM Infoweb Full time ₹ 2,50,000 - ₹ 4,50,000 per year

    AM INFOWEBAct as a mediator between insurance company's/law firms and hospitals, doctors, clinics medical facilities.Do a follow-up on medical reports of patients who have been discharged from the mentioned medical institutes.The main aim is to get the medical facility reports within the time frame mentioned by the client.Key Responsibilities:Handle inbound...

  • Fresher Hiring

    1 week ago


    Pune, Maharashtra, India AM Infoweb Full time ₹ 20,475 - ₹ 25,000 per year

    Job descriptionAM INFOWEBAct as a mediator between insurance company's/law firms and hospitals, doctors, clinics medical facilities. Do a follow-up on medical reports of patients who have been discharged from the mentioned medical institutes.The main aim is to get the medical facility reports within the time frame mentioned by the client.Key...


  • Pune, Maharashtra, India AM Infoweb Full time ₹ 1,50,000 - ₹ 2,50,000 per year

    Job descriptionAM INFOWEBAct as a mediator between insurance company's/law firms and hospitals, doctors, clinics medical facilities. Do a follow-up on medical reports of patients who have been discharged from the mentioned medical institutes.The main aim is to get the medical facility reports within the time frame mentioned by the client.Key...

  • System Specialist

    1 week ago


    Pune, Maharashtra, India Zenith System Solutions Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    :Please find the JD For Below Opening : PID: System Specialist..Technical Skills: Citrix DaaS, Azure, Windows / Active Directory, Entra ID.Role & responsibilities:Citrix & NetScaler:• Experience in performance-monitoring, tuning, scripting, upgrades, Policies, and maintenance activities for Citrix infrastructure.• Make Citrix design/architectural and...