Purpose
This role is responsible for preparation, review, control, and maintenance of manufacturing-related documents such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), SOPs, and logbooks in compliance with Good Manufacturing Practices (GMP) and regulatory requirements. The role ensures accurate documentation to support pharmaceutical manufacturing operations and regulatory compliance.
Position / Job Title
Executive Manufacturing (Documentation)
Department
Production/Manufacturing
Reporting To
Asst. Manager/Manager/Sr. Manager
Location
Indore
Years Of Experience
2–4 years experience in manufacturing documentation or QA documentation in a pharmaceutical formulation company.
Dosage Form
Solid & Semi solid
Job Responsibilities / Deliverables
- Preparation of Manufacturing Documents
- Prepare and issue Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
- Prepare and update Standard Operating Procedures (SOPs) related to manufacturing activities.
- Create and maintain formats, logbooks, and master documents.
- Document Control
- Maintain proper document numbering, version control, and archival system.
- Ensure only approved and controlled copies of documents are issued to production.
- Maintain document issuance and retrieval records.
- Review of Batch Documents
- Review completed BMR/BPR for completeness, accuracy, and compliance.
- Identify and report documentation errors or discrepancies.
- Coordinate with Production and QA for correction and closure.
- Compliance with Regulatory Requirements
- Ensure all documentation follows GMP guidelines and regulatory standards.
- Support documentation requirements for regulatory inspections and audits (such as WHO-GMP, USFDA, MHRA, EU).
- Change Control & Updates
- Update documents based on change control, process improvements, or regulatory requirements.
- Track document revisions and ensure timely updates.
- Coordination with Departments
- Work closely with:
- Production
- Quality Assurance (QA)
- Quality Control (QC)
- Regulatory Affairs
- Ensure timely issuance of documents for manufacturing schedules.
Qualifications Education: B. Pharm / M. Pharm
Additional Notes
Required Skills
- Strong knowledge of GMP documentation practices
- Experience with BMR/BPR preparation and review
- Understanding of document control systems
- Good attention to detail and accuracy
- Familiarity with ERP or document management systems
- Good communication and coordination skills
Key Competencies
- Documentation accuracy
- Regulatory compliance awareness
- Organizational and record management skills
- Time management
- Attention to detai
