Agent
Jobs
Applied
Tracker
Profile
    1. Jobs for you
    2. Job

    Job · 20636652

    AHMEDABAD · FULLTIME

    Sr Executive, Technical Writing

    Amneal Pharmaceuticals

    Amneal Pharmaceuticals

    Ahmedabad · onsite · Posted 12d ago

    Sourced fromNaukri
    Undisclosed5–8 yrsfulltimeAhmedabad

    Your match

    ?

    Sign in to see your match score, skill gaps & tailored resume.

    Section · 01

    About this role

    Description:
    This role is responsible for leading and executing technical writing activities within a regulated pharmaceutical manufacturing environment, ensuring that all technical documents including standard operating procedures, work instructions, technical reports, and related materials are accurate, comprehensive, and compliant with current Good Manufacturing Practices and applicable regulatory requirements. The position takes a senior role in the creation, review, and revision of technical documents that describe manufacturing processes, equipment operations, and quality systems, ensuring clarity and regulatory compliance. It ensures that all technical writing activities are conducted in strict adherence to document control procedures and regulatory standards. The role collaborates with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation. It provides guidance and review support to junior documentation staff and participates in cross-functional initiatives to improve documentation quality and efficiency. Accurate and timely completion of technical writing tasks is a core accountability of this position. The role participates in process improvement initiatives and functional team projects aimed at enhancing documentation quality, efficiency, and compliance. It operates within a highly regulated pharmaceutical environment, ensuring all technical documents meet defined quality and regulatory standards.

    Essential Functions:
    • Lead the preparation, development, and maintece of technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
    • Establish documentation metrics and dashboards to track quality, compliance trends, and team productivity
    • Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation
    • Review and approve existing documentation to identify gaps, inconsistencies, or areas requiring update and escalate findings to relevant stakeholders
    • Ensure all technical documents accurately reflect manufacturing processes, equipment operations, and quality systems
    • Provide guidance and review support to junior documentation staff on documentation standards and cGMP requirements
    • Manage the document control lifecycle including creation, revision, review, approval, and archival of technical documents
    • Maintain accurate and complete documentation records including document revision histories and change control logs
    • Ensure all technical writing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements
    • Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance


    Additional Responsibilities: Education:
    • B. Pharm B. Pharm - Required
    • M. Pharm M. Pharm - Preferred
    Experience:
    • 5 years or more in 5 - 8 Years
    Specialized Knowledge: Licenses:

    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Let the agent run this one for you.

    Tailored resume, auto-apply, and referral lookup — in under 2 minutes.

    Section · 02

    Skills

    CGMPtechnical writingChange ControlProcess ImprovementPharmaceutical ManufacturingManufacturing ProcessesQuality SystemsRegulatory ComplianceManufacturingoperationsmaintenancecompliancePharmaceutical

    Section · Company

    About Amneal Pharmaceuticals

    Amneal Pharmaceuticals

    Amneal Pharmaceuticals

    Pharma

    5.5k+

    employees

    2002

    24 years old

    Bridgewater, New Jersey

    United States (USA)

    About

    Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

    Industries

    PharmaBiotechnologyClinical Research

    Employee ratings

    1,455 reviews

    4.2/ 5

    Culture

    4.0

    Career growth

    3.5

    Work-life

    4.2

    Employees rate it well for

    Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

    Find them on

    WebsiteLinkedInAmbitionBox reviews

    Job search guides

    • All 3,181 jobs in Ahmedabad
    • Auto-apply to jobs like this
    • Tailor your resume for this role
    • Naukri auto-apply, explained
    • How to find a job in India, fast