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.
- 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.
