Computer system validation -- 2

₹12500-37500 INR

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5 tháng trước

₹12500-37500 INR

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I am looking for a freelancer who can help me with the computer system validation of a hardware device. Responsibilities:  Handling and monitoring QA Reviewer and CSV support team.  Monitoring execution of protocols, procedures, and policies to provide support for validation of computerized systems.  Assuring Regulatory Compliance, Understanding of risk based system validation approach.  Process excellence & understanding creations across levels.  Training facilitation of sessions i.e. CSV, QMS, DMS, 21 cfr, SDLC, ISO 9001:2015, GAMP-5, etc.  Analysis and Documentation related to Quality Management Systems (ISO 9001:2015).  Facing external audits, conducting internal audits and maintaining Regulatory compliance with Applicable guidelines.  Project Coordination pertaining to ongoing projects as and when required.  Managing Product Life Cycle & Project Management Plan.  Contribute to the implementation phase of projects, and also offer support to clients to their Requirements. . Skills and experience required: -  Strong written, verbal and documentation skills.  5+ years’ of industrial experience in testing server based, standalone and web based applications.  Strong understanding of SDLC, STLC, 21cfr part 11, GAMP 5 guidelines, SDLC, ICH Q7, Q9 guidelines, US FDA guidelines, EU Annex and Schedule-M.  Functional Testing, Software Testing, Manual Testing, Regression Testing, Agile Methodologies Testing, Grey box testing, Black box testing.  Expertise in GAP Assessment Protocol, VPP, FRS, FRA, DCS, CVC, VP, IQ, OQ, PQ, ATR, TM, SRC VSR and PRR, EDC OQ execution, Incident and Deviation handling  Audit trail review and computer system, server, & IPC/SCADA system verification  Knowledge of validation tools like, MS Sharepoint, Jira, MS Azure.  Experience on Environment monitoring Data Acquisition System, Centrifuge Operation & dryer SCADA, SRP, water system SCADA systems, BPM, VFM, SCM, QAMS, SAP, WnD, LMS, CDAS, LIMS.  Frequent used softwares: Vijeo citect, Factory talkview, 7.00, 8.20, Proficy iFix 5.8, Elipse E3, Zenon runtime, Chromeleon, LIMS, Labware, Rudolph P C

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9 freelancer chào giá trung bình ₹27.111 INR cho công việc này

@freemishra304

Hi there! I am a talented and experienced Senior Tester looking to be hired. Having work experience of more than 10 years in testing domain, I have versatility as Functional/Manual, Database, API/Performance, Mobile and Automation testing which includes the E2E coverage of 'Test planning, Test designing, Logging defects and Preparing Test reports'. Automation tools experience: QTP, UFT, Selenium(Test-NG Framework). Performance/Load Testing tools experience: Load Runner, JMeter, Blaze Meter API Testing tool experience: POSTMAN Project Management Tool experience: HP-ALM, QC, JIRA, MTM, Axosoft. Mobile Testing Tool Experience: SeeTest, Android, iOS Different types of testing experience: Website Testing, UI Testing, Regression Testing, Functional/Manual Testing, Mobile Testing(iOS & Android), Automation Testing, API Testing(Using SOAP /Postman), Penetration Testing, Security Testing. Different domains experience: Banking, E-commerce, B2B, B2C Websites, Digital, Finance, Private Equity, Mobile. I will try to put in my best foot and help you in accomplishing your goals to reach your targeted task. I will involve myself sincerely in your team and can handle as an autonomous person too. You can trust on me for any of your assignments and I will deliver the result in a prompt manner. I am looking forward to be outsourced by you. Please ping me to discuss further on the same thank you

₹12.500 INR trong 1 ngày

4,8

(43 nhận xét)

5,2

@morsadanam

Hello there, Greetings... I read your job posting I am a computer system Validation Expert from India. I have more than 10 years of experience in Validating software as per GAMP5 Guidelines, managing End to End 21 Cfr part 11 and CSV project as per FDA and EU requirements, writing Validation deliverables like URS, FS, Risk Assessment, Test Plan, IQ, OQ, PQ, TM, VSR, execution of test cases, Quality Assurance, SOP writing and QMS Documentation. I have worked with many companies like CIPLA, Torrent Pharma strides shasun, and amenal pharmaceutical, as Validation Manager. Looking forward to work on this project. I am available for a Skype interview. Regards Anam

₹25.000 INR trong 7 ngày

4,8

(2 nhận xét)

4,1

@cesur135

I am dervis, a professional freelancer with extensive experience in testing systems, specifically in the area of industrial automation. I have worked on numerous projects that required me to monitor system validation and ensure regulatory compliance. I have strong written, verbal and documentation skills coupled with thorough industrial experience in testing server-based applications, standalone systems, web-based applications and other software applications. I have 5+ years' of industrial experience in testing end-to-end systems, specifically in the area of validation of computerized systems. My expertise includes functional testing, software testing, manual testing, regression testing and agile methodologies testing among others. Additionally, I have expertise in training sessions i.e. CSV QMS DMS 21cfr ISO 9001:2015. I am highly qualified to handle the Computer System Validation project due to my expertise in process excellence & understanding creations across levels as well as coordination pertaining to ongoing projects as and when required. I am also experienced in managing product life cycle & project management plans as well as contributing to the implementation phase of projects

₹37.000 INR trong 7 ngày

5,0

(1 nhận xét)

0,7

@ArshivFreelancer

Hello I have read your requirement and i can do that Job, As a Software QA Engineer having more than 10+ years experience in Mobile Testing and WEB Testing . I have expertise in Ad-Hoc testing, Agile Testing and Methodology, Regression Testing , UI Testing , User acceptance testing, Smoke Testing. Also having vast testing experience in different domains like banking, finance, ecommerce, hospitality etc.. I will provide the Test cases , Bug Report and Traceability Matrix and also having good experience Bug tracking tool like Test Rail, Jira, Mentis etc.. So let's connect and discuss about your requirement Looking Forward to work with you ! Thank you.

₹32.000 INR trong 7 ngày

5,0

(3 nhận xét)

0,3

@alirafay700

Hi there, my name is Rafay and I am a graphic designer with 5+ years of industrial experience in testing server-based, standalone and web-based applications. I have the necessary skills and experience to help you with your computer system validation project. Specifically, I am responsible for handling and monitoring the QA Reviewer and CSV support team while monitoring execution of protocols, procedures and policies to provide support for validation of computerized systems. Additionally, I ensure Regulatory Compliance by understanding risk-based system validation approach as well as Process Excellence & Understanding across Levels. I also facilitate training sessions i.e. CSV, QMS, DMS, 21 CFR part 11, ISO 9001:2015 GAMP-5 guidelines etc. I specialize in Agile Methodologies Testing as well as Analysis & Documentation related to Quality Management Systems (ISO 9001:2015). I have experience conducting Internal & External Audits as required as well as maintaining Regulatory Compliance with Applicable guidelines..

₹20.000 INR trong 2 ngày

0,0

(0 nhận xét)

0,0

@suryaprakash3002

As a highly skilled and experienced freelancer specializing in PLC, SCADA, VB.NET, Barcode Scanners, and HMI development, I understand the importance of computer system validation for you. With extensive industry experience in testing server based, standalone and web based applications as well as strong understanding of SDLC, STLC, 21cfr part 11, GAMP 5 guidelines, SDLC and ICH Q7 guidelines; I am confident that I can provide the best solution for your needs. I have the necessary skills and experience to handle all aspects of the job from handling and monitoring QA Reviewer and CSV support team to monitoring execution of protocols, procedures and policies to provide support for validation of computerized systems. Additionally I ensure Regulatory compliance by understanding risk based system validation approach. I also provide gap assessment and solution by upgrading system according to regulatory requirement. Successfully completed 100+ Equipment's up-gradation in Different pharma companies to meet 21 CFR Part 11 Compliance. Those equipments include FBD's, RMG's, FBP's, Coating Machines, Blenders, Compression, Reactors, Bin washers, Packing Lines etc. of Different makes which includes Gansons, Glatt, Sezong, Saan, Sainath, Bectochem, ACG, Cybernetic, Matcon etc. We do validations for Upgraded Equipment From PO Release to PQ which includes GAP Assessment Protocol, VPP, FRS, FRA, DCS, CVC, VP, IQ, OQ, PQ.

₹30.000 INR trong 7 ngày

0,0

(0 nhận xét)

0,0

@navinadhami

Hello, I'm Navina, and I have over 5 years of experience in QA management, protocol execution, and regulatory compliance. I am well-prepared to tackle your challenges. My expertise in audit management, training, and project coordination ensures a holistic solution. Outlined below are my approach and strategies for testing and continually enhancing QA: 1. Comprehensive Test Planning 2. Test Case Design and Execution 3. Continuous Integration and Agile Processes 4. Proactive Defect Reporting and Management 5. Continuous Improvement 6. Feedback and Collaboration I am looking forward to the opportunity of working together. Best regards, Navina.

₹37.500 INR trong 20 ngày

0,0

(0 nhận xét)

0,0

@ArielCard

Tengo certificado y estoy sintrabajo asique tengo la mayoria de tiempo para hacer este trabajo como me lo pidan

₹25.000 INR trong 2 ngày

0,0

(0 nhận xét)

0,0

@ssheikh7

Hello I have reviewed the requirements thoroughly. I am writing to express my interest in assisting you with the computer system validation of your hardware device as a freelancer. I have extensive experience in the field and possess the necessary skills and qualifications to successfully handle this project. With over 5 years of industrial experience, I have successfully tested server-based, standalone, and web-based applications. - I have a deep understanding of SDLC, STLC, 21 CFR Part 11, GAMP-5 guidelines, ICH Q7 and Q9 guidelines. - My testing expertise includes functional testing, software testing, manual testing, regression testing, agile methodologies testing, grey box testing, and black box testing. - I am familiar with validation protocols and documents such as GAP Assessments. - I am proficient in audit trail review and computer system, server, and IPC/SCADA system verification. - I have working knowledge of validation tools such as MS SharePoint, Jira, and MS Azure. - I have experience with various software systems including Environment monitoring Data Acquisition Systems. During my work experience I have done multiple project with the similar course therefore I am confident that my skills, experience and proficiency make me an Ideal fit. I can assure you premium work, efficient communication and time bound completion by my end. Best Regards Shizra Sheikh

₹25.000 INR trong 7 ngày