Key Responsibilities for Documentation Officers:

- Manage the development, drafting, revision, distribution, and withdrawal of all controlled documents.
- Maintain a document control system that ensures secure storage, easy retrieval, proper distribution and disposal of documents.
- Ensure documents are clear, concise, and accurately reflect current practices and regulatory standards.
- Establish and maintain document control processes within the SAP DMS, including document creation, review, approval, distribution, and archiving.
- Ensure that only current and approved versions of documents are available to the users, and obsolete documents are appropriately archived / withdrawn.
- Stay updated of regulatory changes that affect documentation requirements.
- Manage the document change control process, ensuring that all changes are documented, justified, reviewed, and approved before implementation.
- Work closely with various departments e.g., R&D;, Quality, Production,



Warehouse, Maintenance, Marketing etc.
- Develop and deliver training programs for end-users on SAP DMS functionalities.
- Provide ongoing support and troubleshooting for SAP DMS users across the organization regarding document management.
- Continuously evaluate and improve document management processes and SAP DMS configurations to enhance efficiency, compliance, and user experience.

Required Skills:

- Awareness and understanding of regulatory requirements and standards (e.g. cGMP, Indian FDA, US FDA 21cfr part 820, Good Documentation Practices, ISO, EU MDR).
- Solid analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office Suite.
- Capable of managing multiple projects and deadlines.

📌 Regulatory Affairs (Haryana)
🏢 Polymed
📍 Haryana