Senior CSV Technical Writer

13 hours ago

Bengaluru, Karnataka, India beBeeTechnical Full time ₹ 9,00,000 - ₹ 12,00,000
Job Description

As a highly skilled Technical Writer, you will play a pivotal role in developing comprehensive and regulatory-compliant documentation for Computerized System Validation (CSV) processes. This involves translating complex technical concepts into clear, accessible language for diverse stakeholders.

Key responsibilities include:

  1. Creating detailed validation plans, security plans, user stories, SOPs, and CAPA reports.
  2. Collaborating with cross-functional teams to gather inputs and feedback.
  3. Applying industry-specific knowledge to ensure documentation meets GxP and GAMP 5 standards.

The ideal candidate will possess a strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks. A bachelor's degree in computer science, Life Sciences, or a related field, along with 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain, is preferred.

Required Skills and Qualifications
  • Strong writing, editing, and stakeholder engagement skills.
  • Excellent knowledge of Data Integration and Analysis, and familiarity with Azure Databricks platforms.
  • Bachelor's degree in computer science, Life Sciences, or related field (Master's preferred).
  • Minimum 5+ years of experience as a technical writer in the pharmaceutical or life sciences domain.
  • Strong understanding of CSV principles, GAMP guidelines, and regulatory frameworks.
Key Benefits

This role offers a unique opportunity to apply your technical writing expertise in a dynamic and fast-paced environment. You will have the chance to work collaboratively with cross-functional teams and contribute to the development of high-quality documentation that meets industry standards.

Additional Information

If you are a motivated and detail-oriented Technical Writer looking to take your career to the next level, we encourage you to apply for this exciting opportunity.

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