Documentation Executive

Job Summary

The Documentation Executive is responsible for creating, reviewing, controlling, maintaining, and archiving all pharmaceutical documents in compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements. The role ensures that documentation is accurate, up-to-date, and readily available to support manufacturing, quality assurance, audits, and regulatory inspections.

Responsibilities

• Prepare, review, issue, revise, and archive controlled documents such as Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), specifications, protocols, reports, forms, and logbooks.
• Maintain the document control system to ensure all documents are properly numbered, approved, distributed, and withdrawn when obsolete.
• Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and company quality policies.
• Coordinate document review and approval workflows with cross-functional departments.
• Maintain master copies of controlled documents and ensure only current versions are available for use.
• Monitor document revision schedules and initiate timely updates.
• Support internal, customer, and regulatory audits by providing required documentation.
• Archive completed documents according to company retention policies and regulatory requirements.
• Maintain confidentiality and security of controlled documents.
• Track document issuance, retrieval, and destruction records.
• Assist in change control, deviation, CAPA (Corrective and Preventive Actions), and risk management documentation.
• Ensure documentation complies with regulatory requirements from authorities such as FDA, EMA, WHO, and local regulatory agencies where applicable.
• Train employees on document control procedures and Good Documentation Practices.
• Support electronic document management systems (EDMS) where implemented.
• Coordinate with Quality Assurance, Production, Quality Control, Regulatory Affairs, Engineering, and Warehouse departments to ensure documentation accuracy and completeness.

Requirements

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Biochemistry, Life Sciences, or a related discipline.
• Additional certification in Quality Management, GMP, or Documentation Control is an advantage.
• 2–5 years of experience in pharmaceutical documentation, quality assurance, regulatory affairs, or manufacturing documentation.
• Experience working in a GMP-compliant pharmaceutical environment is preferred.
• Familiarity with electronic document management systems (EDMS) is desirable.

How to Apply

Interested and qualified candidates should send their CV to: nosa@svnl.in using the Job Title as the subject of the email.