Documentation Writer validation gxp

1 week ago

Bengaluru Karnataka, India 7N Full time

**Mandatory Skills**:

- Experience in category 5 (Customized IT solution) solution implementation.
- Experience writing end to end documentation for IT solutions implementation especially for category 5.
- Understand the term GxP and worked with GxP Systems and Non-GxP systems.
- Concept of risk assessment in the implementation and operation of IT solutions.
- Understand Deviation, how to perform its investigation and propose CAPA for the deviation.
- Handled change management or are you aware of writing change requests.
- Performed periodic review for the IT solution.
- Review and approve/ acknowledge (on behalf of NN QA) validation deliverables including Installation Verification (IV), Operational Verification (OV), Performance Verification (PV) etc.

**Optional Skills: (Good to Have Skills)**:

- Knowledge of PowerApps technologies, Experience in working with Pharma industry client’s
- Experience of working with validation tools such as ADO.
- Experience of handling implementations using Agile framework.

**Roles & Responsibilities**:

- Concept of risk assessment in the implementation and operation of IT solutions.
- Understand Deviation, how to perform its investigation and propose CAPA for the deviation.
- Handled change management or are you aware of writing change requests.
- Performed periodic review for the IT solution.
- Experience of working with validation tools such as ADO.
- Experience of handling implementations using Agile framework.
- Review and approve/ acknowledge (on behalf of NN QA) validation deliverables including Installation Verification (IV), Operational Verification (OV), Performance Verification (PV) etc.

**About 7N**:
Over decades, 7N has been part of several waves of digitalization. Today, our consultants work across industries and geographical borders to deliver the projects that define the new digital realities. We offer a highly specialized portfolio of IT services and solutions delivered by the top 3% of IT professionals. Our expertise spans across many industries, providing digital transformation across all phases of the IT project life cycle.

By engaging early with 7N, you benefit from our experience and expertise when defining the project scope and strategic needs, and you gain flexibility to accommodate changing demands while maintaining control and ownership of IT development.

  • GxP Validation and Compliance Specialist

    6 days ago

    Bengaluru, Karnataka, India micro1 Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Title: GxP Validation and Compliance SpecialistJob type:Full-time, ContractLocation:Hybrid (Bengaluru, Hyderabad, Delhi, Pune)About Us:Our mission at micro1 is to match the most talented people in the world with their dream jobs. If you are looking to be at the forefront of AI innovation and work with some of the fastest-growing companies in Silicon...

  • GxP Compliance Specialist

    3 weeks ago

    Bengaluru, India ACL Digital Full time

    We are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices. The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation including...

  • Csv , Gxp

    2 days ago

    Bengaluru, Karnataka, India NTT DATA Full time

    **Req ID**: 338619 We are currently seeking a CSV, GxP to join our team in Bangalore, Karnātaka (IN-KA), India (IN). Mid-senior level test analyst, about 3-6 years Mandatory Skills: CSV, STLC Principles, GxP, 21 CFR Part 11, good written and Verbal communication skills, good knowledge of Testing tools like HPALM (TIMS), working experience in Agile...

  • ▷ 3 Days Left! GxP Validation

    4 weeks ago

    Bengaluru, India Prana Tree Full time

    Job Description Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role OverviewWe are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory...

  • Computer Validation Engineer(CSV)

    3 weeks ago

    Bengaluru, Karnataka, India, Karnataka ACL Digital Full time

    We are seeking a highly skilled and detail-oriented CSV Technical Writer to join our team. This role demands strong documentation capabilities, effective communication, and deep exposure to the pharmaceutical industry and CSV practices. The ideal candidate will be proficient in stakeholder management, user story writing, and technical documentation including...

  • Csv , Compliance Gxp

    2 days ago

    Bengaluru, Karnataka, India NTT DATA Full time

    **Req ID**: 338618 We are currently seeking a CSV, Compliance Gxp to join our team in Bangalore, Karnātaka (IN-KA), India (IN). **Job Description**: - Skill Area: CSV, Compliance Gxp, Infrastructure support - Main Technology: Compliance - Mandatory Skills: (Must Have Skills) - GxP, Compliance, CSV knowledge, Qualification and Maintenance - Optional...

  • GXP Systems

    3 weeks ago

    Bengaluru, India Anicalls (Pty) Ltd Full time

    • 3 years of hands-on experience maintaining quality control of an I.T. environment • 2 years of experience supporting GxP laboratory applications and systems • Understanding of GAMP 5, 21 CFR Part 11, Computer System Validation, and Change Control • Working knowledge of Active Directory/LDAP and Windows Security • Detail-oriented with...

  • GXP Tester

    5 days ago

    Bengaluru, Hyderabad, Pune, India Prointegrate World It Consulting Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    JD:GxP Manual Functional Tester:• Minimum 6+ years of experience in manual testing in GxP-compliant environments• Good understanding of STLC, Functional testing, FIT, UAT, Defect Management• Hands on experience in FIT Test case design and executions• Hands on experience in UAT test design• Working experience with Agile Incremental testing•...

  • Validation Engineer

    1 week ago

    Bengaluru, Karnataka, India Esscorptech Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Responsibilities:* Develop validation plans, execute tests, document results.* Ensure compliance with GXP, 21 CFR Part 11, GMP, FDA standards.* Collaborate with cross-functional teams on system installations.Other Loca:Chennai,Pune,Mumbai,Kolkata

  • Computer System Validation Leader/Manager

    2 days ago

    Bengaluru, India People Prime World Wide Full time

    About Company : . Our client is a trusted global innovator of IT and business services. They help clients transform through consulting, industry solutions, business process services, digital & IT modernization and managed services. Our client enables them, as well as society, to move confidently into the digital future. We are committed to our clients'...