Technical Writer | IT Compliance Specialist (GAMP-5)

Application











    Posted on February 3rd, 2025

    Technical Writer | IT Compliance Specialist (GAMP-5)

    WHAT WE’RE UP TO

    WE ARE A LEAN, TENACIOUS MACHINE POWERED BY 85 OF THE SHARPEST, MOST PASSIONATE PEOPLE WE COULD FIND.

    Simelabs is a product-driven venture-development firm that works with a range of startups and big brands to create compelling, successful, award-winning application. We help people perfect and realise their visions for digital products. While others may just churn out what a client asks for, we strive to truly understand the problems our clients are aiming to solve and will stop at nothing to build solid products that we’re proud of.

    Roles and Responsibilities

    • Development of Protocol for IT Network qualification as per GAMP-5 Guidelines, (Cat-1) requirements.
    • Development of the IT SOPs – ➢ SOP for Life cycle management of computerized systems, along with all necessary templates.
    • SOP for Data backup and restoration of electronic data
    • SOP for User management and control with logical securities.
    • SOP for Electronic data review, audit trail review.
    • SOP for Inventory management of GxP systems.
    • SOP for Preventive maintenance of IT systems.
    • SOP for Incident management procedures.
    • SOP for Release management and assessments.
    • Policy for Disaster management programs.

    The Ideal Candidate

    Got what it takes?

    Want to join the team? Submit your application—
    we respond to most inquiries within three business days.

    I Want to Join

    Perks and Benefits

    • 12 Paid Company Holidays

    • 6 Paid Sick Leave

    • Group Health Plan insurance Employee, Spouse and dependent

    • Performance Bonus

    • Flexible time

    • Work Life Balance