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 transparent, 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and approved versions of documents are available to the users, and obsolete documents are appropriately archived / withdrawn.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, Positive 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