Senior CSV Systems Validation Specialist

1 day ago

Hyderabad, Telangana, India beBeeCsv Full time ₹ 80,00,000 - ₹ 1,50,00,000

We are seeking an experienced CSV Analyst to join our team as a Lead Consultant.

About the Role

This is an exciting opportunity for a skilled professional to leverage their expertise in system requirements development, validation planning, and testing methodologies. As a Lead Consultant CSV Analyst, you will play a critical role in ensuring the compliance of computer systems with 21 CFR Part 11 regulations.

Key Responsibilities:
  • System Requirements Development
  • Evaluate proposed changes to validated computer systems and recommend validation activities.
  • Identify and qualify computer systems impacting cGMP operations using a risk-based methodology.
  • Develop CFR Part 11 computer systems validation plans, qualifications test protocols, and reports.
  • Ensure proper software documentation from suppliers and identification of associated unit and deployment testing.
  • Develop and maintain test plans, test scripts, and user acceptance tests, and manage their execution.
Qualifications and Skills:
  • Required Qualifications:
    • Bachelor's degree in a relevant field.
  • PREFERRED QUALIFICATIONS:
    • Familiarity with writing tests for Web-based software architectures.
    • Knowledge of Software validation process and testing methodologies in a highly regulated environment.
    • Familiarity with pharmaceutical or medical device industry legal requirements (cGMP's, 21CFR part11, GAMP).
    • Critical thinker and problem-solving skills.
    • Team player.
    • Good level in English.
    • Great interpersonal and communication skills.

The ideal candidate will have a strong understanding of software validation processes and testing methodologies, as well as experience working in a highly regulated environment.

  • Computer System Validation(CSV) 3

    1 week ago

    Hyderabad, Telangana, India Alignity Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Do you love a career where you Experience, Grow & Contribute at the same time, while earning at least 10% above the market? If so, we are excited to have bumped onto you.Learn how we are redefining the meaning of work, and be a part of the team raved by Clients, Job-seekers and Employees.Jobseeker Video Testimonials  Employee Glassdoor ReviewsIf you are a...

  • Computer System Validation(CSV) 3

    21 hours ago

    Hyderabad, Telangana, India Alignity Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Do you love a career where you Experience, Grow & Contribute at the same time, while earning at least 10% above the market? If so, we are excited to have bumped onto you. Learn how we are redefining the meaning of work, and be a part of the team raved by Clients, Job-seekers and Employees. Jobseeker Video Testimonials Employee Glassdoor Reviews ...

  • CSV Expert

    23 hours ago

    Hyderabad, Telangana, India VAK Consulting Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Seeking a professional with 5+ yrs in Computer System Validation (CSV) in regulated (GxP) environments. Expertise in CSV/SDLC, regulatory standards, Spotfire, Statistica, Redshift, and strong problem-solving, documentation, and communication skills

  • Digital Systems Validator

    1 day ago

    Hyderabad, Telangana, India beBeeCsv Full time ₹ 20,00,000 - ₹ 25,00,000

    Azurity Pharmaceuticals, a specialty pharmaceutical company focusing on innovative products for underserved patients, seeks a motivated IT professional.The company's patient-centric products span multiple markets and have benefited millions of patients. We are an inclusive workplace and an Equal Opportunity Employer.We are looking for individuals with...

  • Computer System validation

    23 hours ago

    Hyderabad, Telangana, India HCLTech Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Greetings from HCLHiring for "Computer system validation"Experience- 8-20 YearsLocation- Bangalore / Noida / Chennai / Hyderabad / PuneCTC- Can be discussedJD:Computer System Validation ManagerMandatory Skills CSV Manager, Compliance and Assurance services, LIFESCIENCES GXP FDA CSV IQOQPQ, Leading Offshore CSV Team to drive validation deliverables , Stake...

  • SAP CSV Consultant

    20 hours ago

    Hyderabad, Telangana, India ITCAN Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    About the Role :We are seeking a highly experienced and skilled Senior SAP CSV Consultant to join our team. In this critical role, you will be responsible for ensuring the compliance of SAP implementations with regulatory requirements. You will lead and execute validation activities across the entire software development lifecycle, from initial design to...

  • Lead Consultant CSV Analyst

    2 days ago

    Hyderabad, Telangana, India Genpact Full time

    Job DescriptionInviting applications for the role of Lead Consultant - CSV AnalystIn this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution.Responsibilities. Assist with the development of system requirements and specifications to ensure...

  • Senior Validation Specialist

    3 days ago

    Hyderabad, Telangana, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000

    Job OpportunityWe are seeking a skilled Validation Professional to join our team.Mandatory Requirements:Hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR...

  • Senior Validation Engineer

    4 weeks ago

    Hyderabad, Telangana, India Tek Support Full time

    Job DescriptionJob Title: Validation Training Engineer QC & Automation SystemsLocation: Hyderabad, Telangana, IndiaEmployment Type: Full-TimeIndustry: Pharmaceuticals / Biologics / Medical DevicesJob Overview:We are seeking a Validation Training Engineer to design, deliver, and maintain training programs for Quality Control (QC) laboratory systems, computer...

  • Senior Validation Engineer

    1 week ago

    Hyderabad, Telangana, India Tek Support Full time

    Job Title: Validation Training Engineer – QC & Automation Systems Location: Hyderabad, Telangana, India Employment Type: Full-Time Industry: Pharmaceuticals / Biologics / Medical Devices Job Overview: We are seeking a Validation Training Engineer to design, deliver, and maintain training programs for Quality Control (QC) laboratory...