Validation Analyst

Navikenz; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading business solutions provider in Bengaluru is seeking an experienced Technical Writer to create and maintain various technical documents including SOPs, Work Instructions, Reports, and User Manuals. The ideal candidate will have 3–8 years of technical writing experience, with a strong emphasis on validation processes. Familiarity with regulated environments, excellent communication skills, and the ability to manage documentation projects are essential. This is a full-time role located in Karnataka, India.

Qualifications

• 3–8 years of experience in technical writing or documentation.
• At least 2–3 years in validation (equipment, process, or software).
• Strong understanding of validation processes such as IQ/OQ/PQ.

Responsibilities

• Create and maintain technical documents like SOPs and User Manuals.
• Develop validation protocols and reports for systems.
• Ensure compliance with documentation standards.

Skills

Technical writing

Communication skills

Analytical skills

Attention to detail

Education

Bachelor’s degree in engineering, Life Sciences, or related field

Tools

Document Management Systems (Veeva, Jira, Confluence, SharePoint)

Job description

Full-Time / Bangalore Noida / / Business Solutions

Documentation Responsibilities

• Create and maintain technical documents including SOPs, Work Instructions, Validation Protocols (IQ/OQ/PQ), Reports, User Manuals, and Process Documentation.
• Draft high‑quality, structured documents aligned with internal standards and regulatory requirements.
• Ensure clarity, accuracy, and consistency in all documentation materials.

Validation Activities

• Develop validation protocols and reports for systems, equipment, processes, and software applications.
• Support execution of validation activities, documenting deviations and ensuring traceability.
• Maintain validation documentation in accordance with compliance guidelines (e.g., GxP, ISO, FDA, EU Annex standards where applicable).

Quality & Compliance

• Ensure documents meet compliance expectations and follow controlled document formats.
• Participate in internal audits, addressing document‑related findings.
• Monitor documentation lifecycle, version control, and archival.
• Work closely with SMEs, QA, Engineering, IT, and Operations teams to gather information and update documents.
• Review documentation created by peers, provide constructive feedback.
• Manage review cycles, approvals, and change control processes.

Required Skills & Qualifications

• Bachelor’s degree in engineering, Life Sciences, Technical Writing, English, or related field.
• 3–8 years of experience in technical writing or documentation, with at least 2–3 years in validation (equipment, process, or software).
• Strong understanding of validation processes such as IQ/OQ/PQ, CSV (Computer System Validation), or related methodologies.
• Excellent written communication, grammar, and document structuring skills.
• Experience working in regulated environments (Pharma, Biotech, Medical Devices, IT Compliance, Manufacturing, etc.).
• Familiarity with Document Management Systems (Veeva, Jira, Confluence, SharePoint, etc.).

Preferred Qualifications

• Knowledge of GxP, FDA 21 CFR Part 11, ISO 9001/13485, or similar standards.
• Experience supporting audits and regulatory inspections.
• Ability to translate complex technical information into user-friendly content.
• Strong analytical, attention-to-detail, and organizational skills.

Soft Skills

• Excellent communication and interpersonal abilities.
• Ability to manage multiple documentation projects simultaneously.
• Strong ownership mindset and willingness to collaborate across functions.
• Adaptable, process-driven, and quality-focused.