Key Responsibilities:

Documentation Development:

- 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.

Collaboration & Review:

- 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.

- 12+ years of experience in technical writing or documentation, with at least 6+ 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.

- Solid 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.

📌 Validation Lead (India)
🏢 Navikenz
📍 India